Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts

Sunday, March 11, 2018

March 2018 - Recruiting hepatitis C clinical trials

March 2018 - Recruiting hepatitis C clinical trials
After 2017 the market for new hepatitis C drugs pretty much peaked, leaving people with fewer clinical trials to consider. Below is a small list of trials for adults and children. A few trials for adults that have previously treated or are treatment naïve, with or without cirrhosis. Other trials include patients with substance abuse issues, recently acquired hepatitis C infection, with or without HIV co-infection, with kidney disease, or have received a liver transplant, and as mentioned a few trials for children aged 3 years up to 18 years.

ClinicalTrials.gov
The clinical trials listed on this page can be found online at ClinicalTrials.gov. A Web site maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

*This is not a complete list of trials, visit ClinicalTrials.gov and search by Country.

CenterWatch
For viral hepatitis C international trials, or in the US and Canada, search CenterWatch.
CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties.

Recruiting
HCV Genotype 1a or 1b
38 study locations: Liver Wellness Center Little Rock, Arkansas, United States Stanford University Palo Alto, California, United States UCSD Medical Center San Diego, California, United States (and 35 more...)
Study of Oral Treatments for Hepatitis C (PRIORITIZE)
Drug: sofosbuvir/ledipasvir
Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only)
Drug: elbasvir/grazoprevir
Drug: Dasabuvir
ClinicalTrials.gov Identifier: NCT02786537
Patients being prescribed HCV treatment who can begin treatment with any of the three HCV treatments being studied (Harvoni, Viekira Pak (Phase 1 only), or Zepatier)Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.

HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication)  - HCV genotype 1-6
34 locations; United States, Canada, United Kingdom, Australia, Germany, France, Switzerland, and more..
Drug: glecaprevir (300mg)/pibrentasvir (120mg)

ClinicalTrials.gov Identifier: NCT03117569
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.

Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification.

Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.

One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).


Treated Previously - failed to eradicate hepatitis C, Recurrent HCV GT-1
Institute of Human Virology Baltimore, Maryland, United States
Drug: Sofosbuvir/Velpatasvir/Voxilaprevir
ClinicalTrials.gov Identifier: NCT02745535
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.

Treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.
115 locations; University of South Alabama Mobile, Alabama, United States St. Josephs Hosp and Med Ctr Phoenix, Arizona, United States Mayo Clinic Arizona Phoenix, Arizona, United States (and 112 more...)
Drug: Glecaprevir/Pibrentasvir
ClinicalTrials.gov Identifier: NCT03089944
A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.

Cirrhosis - CPT score of 10 to 12, inclusive, as determined at screening, if post-liver transplant, then Day1 must be ≥ 6 months from date of transplant
University of Colorado Denver and Hospital (Leprino Building) Aurora, Colorado, United States
Tampa General Medical Group Tampa, Florida, United States
Northwestern Memorial Hospital; Clinical Research Unit Chicago, Illinois, United States
(and 19 more...)
Drug: SOF/VEL
Drug: RBV
ClinicalTrials.gov Identifier: NCT02994056
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class C cirrhosis.

Recently acquired hepatitis C virus infection with or without HIV co-infection
St Vincent's Hospital Sydney, New South Wales, Australia Royal Adelaide Hospital Adelaide, South Australia, Australia Alfred Hospital Melbourne, Victoria, Australia (and 6 more...)
Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P
Drug: Paritaprevir/ritonavir/ombitasvir
Drug: Dasabuvir
Drug: Ribavirin
Drug: Glecaprevir/pibrentasvir
ClinicalTrials.gov Identifier: NCT02634008
An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.

Recently acquired hepatitis C virus infection with or without HIV co-infection
Massachusetts General Hospital Boston, Massachusetts, United States Kirketon Road Centre
Sydney, New South Wales, Australia St. Vincent's Hospital Sydney, New South Wales, Australia
(and 12 more...)
Drug: SOF/VEL for 6 weeks
Drug: SOF/VEL for 12 weeks
ClinicalTrials.gov Identifier: NCT02625909
The aim of the study is to determine if treatment for recently acquired hepatitis C infection (with or without HIV coinfection) can be shortened when treating with the interferon-free therapy sofosbuvir/velpatasvir (SOF/VEL). 

Substance Abuse - People who inject drugs, HCV genotype 1 or 4
Kirketon Road Centre Darlinghurst, New South Wales, Australia St Vincent's Hospital Darlinghurst, New South Wales, Australia The Langton Centre Darlinghurst, New South Wales, Australia (and 2 more...)
Drug: Grazoprevir/elbasvir
ClinicalTrials.gov Identifier: NCT02940691
This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use and chronic HCV genotype 1 or 4 infection.

Substance Abuse - treatment-naïve alcoholic subjects with Genotype 1 HCV infection
University of Nebraska Omaha, Nebraska, United States
Drug: EBR/GZR
ClinicalTrials.gov Identifier: NCT02759861
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection

Liver Transplant Recipients
Medstar Georgetown University Hospital Washington, District of Columbia, United States Emory University Hospital Atlanta, Georgia, United States University of Pittsburgh Medical Center Pittsburgh, Pennsylvania, United States Medical University of South Carolina Charleston, South Carolina, United States
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
Drug: Sofosbuvir/Ledipasvir x 8 weeks
Drug: Sofosbuvir/Ledipasvir x 12 weeks
Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
ClinicalTrials.gov Identifier: NCT02631772
The predominant remaining questions for post-transplant treatment of HCV in the DAA era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft. Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study

Kidney Disease
Johns Hopkins Hospital/University Baltimore, Maryland, University of Miami Hospital Boston, Massachusetts, United States Henry Ford Health System Detroit, Michigan, United States (and 25 more...)
Drug: LDV/SOF
ClinicalTrials.gov Identifier: NCT03036839
The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal Disease (ESRD).

Children
Children's Hospital Los Angeles, Los Angeles, California, University of California, San Francisco San Francisco, California, Children's Hospital of Colorado Aurora, Colorado (and 17 more...)
Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Drug: SOF/VEL
ClinicalTrials.gov Identifier: NCT03022981
The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.

Univ of California San Francis San Francisco, California, United States Childrens Hospital Colorado
Aurora, Colorado, United States CT Childrens Medical Ctr, US Hartford, Connecticut, United States
(and 34 more...)
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
Drug: Glecaprevir/Pibrentasvir
ClinicalTrials.gov Identifier: NCT03067129
An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults.

Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include participants who are in 12 to < 18 years of age who can swallow the adult formulation of GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.

Children's Hospital of Pittsburgh ( Site 0024) Pittsburgh, Pennsylvania, United States American Research Corporation ( Site 0200) San Antonio, Texas, United States Children's Hospital and Medical Center, [Seattle, WA] ( Site 0017) Seattle, Washington, United States (and 5 more...)Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
Drug: EBR/GZR
ClinicalTrials.gov Identifier: NCT03379506
The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of MK-5172, a fixed dose combination (FDC) of elbasvir (EBR) and grazoprevir (GZR) in pediatric hepatitis C virus (HCV)-infected participants aged 3 years up to 18 years.

Cryoglobulinemia
Icahn School of Medicine at Mount Sinai New York, New York, United States
Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia
Drug: Harvoni
ClinicalTrials.gov Identifier: NCT02825212
Estimated Enrollment : 10 participants
10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with cirrhosis).
The researchers anticipate that approximately 20% of subjects may have cirrhosis.


Not Recruiting Yet
ID CARE Hillsborough, New Jersey, United States
Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study (ELIMINATEC)
Drug: Glecaprevir-pibrentasvir
ClinicalTrials.gov Identifier: NCT03364725
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.

Recommended
Check out HCV Advocate for an easy to navigate HCV Medications Blog with a list of currently FDA approved drugs to treat the hepatitis C virus, organized by HCV genotype.

Monday, May 22, 2017

May 2017 - Recruiting and upcoming hepatitis C clinical trials 

May 2017 - Recruiting and upcoming hepatitis C clinical trials

This is not a complete list of hepatitis C clinical trials, to find out if a study is enrolling patients in your area please click here.

The clinical trials listed on this page can be found online at ClinicalTrials.gov. A Web site maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

For viral hepatitis clinical trials listed by state visit CenterWatch.
CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties.

HCV Advocate

Clinical Trials Reference Guide
Users can search for a hepatitis C clinical trial by category (genotype), or learn how to evaluate a clinical trial and become familiar with commonly used terms. HCV Advocate offers an easy to navigate HCV Medications Blog as well, organized by HCV genotype.

Recommended Reading
Index of current articles with data about investigational regimens to treat the hepatitis C virus.
This review summarizes the clinical potential of velpatasvir-sofosbuvir, velpatasvir-voxilaprevir-sofosbuvir and glecaprevir-pibrentasvir, discussing key results and future directions.

Helpful Links
Premier Hepatitis C Websites, Blogs and Support Forums

https://clinicaltrials.gov/ct2/results?term=hepatitis+c&Search=Search
____________________________________________
This study is currently recruiting participants
United States Puerto Rico
Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
ClinicalTrials.gov Identifier:
NCT03118843
First received: April 13, 2017
Last updated: May 10, 2017
Last verified: May 2017
The primary objectives of this study are to determine the efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks as measured by the proportion of participants with sustained viral response 12 weeks after cessation of treatment (SVR12) and to evaluate the safety and tolerability of treatment with SOF/VEL/VOX FDC.
____________________________________________
This study is currently recruiting participants
United States, Maryland
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Subjects With Previous DAA Experience

ClinicalTrials.gov Identifier:
NCT02745535
First received: April 11, 2016
Last updated: March 21, 2017
Last verified: March 2017
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.
____________________________________________
This study is currently recruiting participants
United States
ClinicalTrials.gov Identifier:
NCT02994056
First received: December 13, 2016
Last updated: April 17, 2017
Last verified: April 2017
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class C cirrhosis.
____________________________________________
This study is currently recruiting participants
United States Belgium Italy United Kingdom
ClinicalTrials.gov Identifier:
NCT03022981
First received: January 13, 2017
Last updated: May 17, 2017
Last verified: May 2017
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.
The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.
The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
____________________________________________
This study is currently recruiting participants
51 Study Locations United States, Australia, Belgium, India, Italy, New Zealand, United Kingdom
Sponsor: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02175758
Purpose
This study will have two parts as follows:
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively. 
____________________________________________
Recruiting
34 Study Locations United States United Kingdom New Zealand Australia United Kingdom
Sponsor: Gilead Sciences
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin in Adolescents and Children With Chronic HCV-Infection
ClinicalTrials.gov Identifier: NCT02249182
Purpose
This study will have two parts as follows:
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/- Ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.
____________________________________________
This study is currently recruiting participants
Australia
A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use
ClinicalTrials.gov Identifier:
NCT02336139
First received: January 4, 2015
Last updated: May 15, 2016
Last verified: May 2016
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.
____________________________________________
This study is currently recruiting participants
Japan
ClinicalTrials.gov Identifier:
NCT02996682
First received: December 15, 2016
Last updated: May 3, 2017
Last verified: May 2017
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic HCV infection and decompensated cirrhosis.
____________________________________________
This study is currently recruiting participants
China Vietnam Thailand Singapore Malaysia
ClinicalTrials.gov Identifier:
NCT02671500
First received: January 29, 2016
Last updated: May 3, 2017
Last verified: May 2017
This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in treatment-naive and treatment-experienced participants with chronic hepatitis C virus (HCV) infection.
____________________________________________
This study is currently recruiting participants
New Zealand
NCT02728206
First received: March 31, 2016
Last updated: March 29, 2017
Last verified: March 2017
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.
____________________________________________
This study is currently recruiting participants
India
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
ClinicalTrials.gov Identifier:
NCT03074331
First received: February 24, 2017
Last updated: May 18, 2017
Last verified: May 2017
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.
____________________________________________
This study is currently recruiting participants
United States, Nebraska
Sponsor: University of Nebraska
Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
ClinicalTrials.gov Identifier: NCT02759861
Purpose
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
____________________________________________
This study is currently recruiting participants
Sponsor: University of Florida
45 study locations in the United States
Sponsor: University of Florida
ClinicalTrials.gov Identifier: NCT02786537
Purpose
Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.
Drug: sofosbuvir/ledipasvir
Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only)
Drug: elbasvir/grazoprevir
Drug: Dasabuvir
____________________________________________
This study is currently recruiting participants
United States
ClinicalTrials.gov Identifier:
NCT03092375
First received: March 21, 2017
Last updated: May 19, 2017
Last verified: May 2017
The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
____________________________________________
This study is currently recruiting participants
United States Australia Belgium Canada France  New Zealand Singapore South Africa
ClinicalTrials.gov Identifier:
NCT02966795
First received: November 15, 2016
Last updated: April 14, 2017
Last verified: April 2017
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for an 8- or 12-week treatment duration in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis, who are either HCV treatment-naïve or treatment experienced with interferon (IFN) or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF plus RBV treatment-experienced).
____________________________________________
This study is currently recruiting participants
United States Puerto Rico
ClinicalTrials.gov Identifier:
NCT03067129
First received: February 24, 2017
Last updated: April 28, 2017
Last verified: April 2017
An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults.
Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include participants who are in 12 to < 18 years of age who can swallow the adult formulation of GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.
____________________________________________
Expanded access is currently available for this treatment.
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com
Expanded Access to Glecaprevir/ Pibrentasvir
NCT03123965
First received: April 18, 2017
Last updated: NA
Last verified: April 2017
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
____________________________________________
This study is currently recruiting participants
United States Italy Puerto Rico
ClinicalTrials.gov Identifier:
NCT03089944
First received: March 22, 2017
Last updated: April 28, 2017
____________________________________________
This study is currently recruiting participants
United States Canada Italy Puerto Rico
ClinicalTrials.gov Identifier:
NCT03069365
First received: February 28, 2017
Last updated: April 28, 2017
Last verified: April 2017
This Phase 3b, open-label, non-randomized study will evaluate the efficacy and safety of Glecaprevir/Pibrentasvir (GLE/PIB) for 8, 12, or 16 weeks in in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection with or without compensated liver cirrhosis and with chronic renal impairment in both HCV treatment-naïve and prior treatment-experienced participants.
____________________________________________
This study is not yet open for participant recruitment
France
ClinicalTrials.gov Identifier:
NCT02973503
First received: October 14, 2016
Last updated: November 22, 2016
Last verified: November 2016
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis
____________________________________________
This study is not yet open for participant recruitment
ClinicalTrials.gov Identifier:
NCT02940691
First received: October 19, 2016
Last updated: October 20, 2016
Last verified: October 2016
This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use and chronic HCV genotype 1 or 4 infection.
____________________________________________
This study is not yet open for participant recruitment
Sponsor: Fundacion SEIMC-GESIDA
Spain
ClinicalTrials.gov Identifier:
NCT03105349
First received: March 16, 2017
Last updated: April 6, 2017
Last verified: March 2017
This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A
____________________________________________
This study is not yet open for participant recruitment
Sponsor: Kirby Institute
Australia Canada New Zealand
NCT03117569
First received: April 7, 2017
Last updated: April 12, 2017
Last verified: April 2017
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.
Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification.
Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.
One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).
____________________________________________
This study is not yet open for participant recruitment
France
ClinicalTrials.gov Identifier:
NCT03111108
First received: April 6, 2017
Last updated: NA
Last verified: March 2017
The purpose of this study was to evaluate the efficacy of each treatment arm using a fixed dose combination (FDC) of EBR/GZR as assessed by the percentage of participants achieving sustained virologic response, defined as HCV ribonucleic acid (RNA) <Lower Limit of Quantitation (LLOQ) 12 weeks after the end of all study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.
____________________________________________
This study is currently recruiting participants
Over 20 study locations in the United States, France, Germany, Spain, Sweden
Sponsor: Merck Sharp & Dohme Corp.
Efficacy and Safety of MK-3682B (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)
ClinicalTrials.gov Identifier: NCT02613403
Purpose
This is a randomized, multicenter, open-label trial of the combination regimen of MK-5172 (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (ruzasvir) (60 mg) for 16 weeks with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously failed a direct-acting antiviral regimen (DAA). The combination regimen will be administered as two fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily.
The study will evaluate the efficacy of the combination regimen of MK-5172 (GZR), MK-3682 and MK-8408 (ruzasvir) with or without ribavirin as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.
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This study is currently recruiting participants
United States, Texas, New Zealand
Sponsor: Merck Sharp & Dohme Corp.
Efficacy and Safety of MK-3682 + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)
ClinicalTrials.gov Identifier: NCT02956629
Purpose
This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug combination regimen (MK-3682 450 mg + ruzasvir [RZR; MK-8408] 180 mg once daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN) or treatment-experienced (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3, GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy. Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency virus (HIV) co-infection will be enrolled.

This is not a complete list of clinical trials, to find out if a study is enrolling patients in your area please click here.

Tuesday, March 7, 2017

March 2017 Update - Recruiting and upcoming hepatitis C clinical trials

March 2017 Update - Recruiting and upcoming hepatitis C clinical trials

This is not a complete list of hepatitis C clinical trials, to find out if a study is enrolling patients in your area please click here.

The clinical trials listed on this page can be found online at ClinicalTrials.gov. A Web site maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

For viral hepatitis clinical trials listed by state visit CenterWatch.
CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties.

HCV Advocate
Clinical Trials Reference Guide
Users can search for a hepatitis C clinical trial by category (genotype), or learn how to evaluate a clinical trial and become familiar with commonly used terms. HCV Advocate offers an easy to navigate HCV Medications Blog as well, organized by HCV genotype.

Recommended Reading
This update reviews some upcoming therapies for the treatment of chronic hepatitis C.

On This Blog 
Click on the menu located across the top of the page to review research articles that correlate with the drugs used in the following clinical trials.
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Recruiting
United States, Maryland
Sponsor: University of Maryland
ClinicalTrials.gov Identifier: NCT02745535
Purpose
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/GS-9857 (SOF/VEL/GS-9857) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.
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Recruiting
ClinicalTrials.gov Identifier: NCT02671500
Purpose
This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in treatment-naive and treatment-experienced participants with chronic hepatitis C virus (HCV) infection.
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Recruiting
United States
Sponsor: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02994056
Purpose
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class C cirrhosis.
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Recruiting
Spain
Sponsor: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02781558
Purpose
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed dose combination (FDC) and SOF/VEL FDC and Ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 HCV infection and compensated cirrhosis.
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Recruiting
Japan
Sponsor: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02996682
Purpose
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic HCV infection and decompensated cirrhosis.
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Recruiting
United States, Belgium, Italy, United Kingdom
Sponsor: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03022981
Purpose
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.
The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.
The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
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Recruiting
Australia, New South Wales
Sponsor: Kirby Institute
A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use (SIMPLIFY)
ClinicalTrials.gov Identifier: NCT02336139
Purpose
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.
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Recruiting
New Zealand
Sponsor: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02728206
Purpose
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.
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Recruiting
United States
Sponsor: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT02605304
Purpose
People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of the infection when they are treated with sofosbuvir. However, in some instances, treatment with sofosbuvir-containing therapy does not work. It is not known if treating people with sofosbuvir again (retreatment) after it did not work the first time will work. There is an important need to understand retreatment options in those instances. This study is being done to see if two different regimens, ledipasvir with sofosbuvir and ribavirin for 12 weeks (Group A) and ledipasvir with sofosbuvir for 24 weeks (Group B) are well tolerated in HCV-infected persons where previous treatment with sofosbuvir failed. This study will also look at the safety of each regimen and how well the combination treatment of ledipasvir/sofosbuvir works in people who have cirrhosis (scarring of the liver) or HIV.
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Recruiting
United States
Sponsor: Medical University of South Carolina
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
ClinicalTrials.gov Identifier: NCT02631772
Purpose
The predominant remaining questions for post-transplant treatment of HCV in the DAA era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft.
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Recruiting
51 Study Locations United States, Australia, Belgium, India, Italy, New Zealand, United Kingdom
Sponsor: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02175758
Purpose
This study will have two parts as follows:
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively. 
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Recruiting
34 Study Locations United States United Kingdom New Zealand Australia United Kingdom
Sponsor: Gilead Sciences
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin in Adolescents and Children With Chronic HCV-Infection
ClinicalTrials.gov Identifier: NCT02249182
Purpose
This study will have two parts as follows:
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/- Ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.
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Recruiting
United States, Nebraska
Sponsor: University of Nebraska
Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
ClinicalTrials.gov Identifier: NCT02759861
Purpose
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
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Recruiting
45 study locations in the United States
Sponsor: University of Florida
ClinicalTrials.gov Identifier: NCT02786537
Purpose
Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.
Drug: sofosbuvir/ledipasvir
Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only)
Drug: elbasvir/grazoprevir
Drug: Dasabuvir
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Recruiting
Sponsor: AbbVie
ClinicalTrials.gov Identifier: NCT02582671
Purpose
This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± RBV in chronic hepatitis C virus infected participants across Ireland.
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Recruiting
Sponsor: AbbVie
ClinicalTrials.gov Identifier: NCT02581189
Purpose
This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Canada.
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Recruiting
United States, Australia, Belgium, Canada, France, Singapore, South Africa
Sponsor: AbbVie
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
ClinicalTrials.gov Identifier: NCT02966795
Purpose
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for an 8- or 12-week treatment duration in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis, who are either HCV treatment-naïve or treatment experienced with interferon (IFN) or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF plus RBV treatment-experienced).
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Recruiting
Australia, New South Wales
Sponsor: Kirby Institute
A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection
ClinicalTrials.gov Identifier: NCT02498015
Purpose
A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with genotype 1a infection or cirrhosis will receive 12 weeks of open-label paritaprevir/ritonavir/ombitasvir and dasabuvir ("3D"), and twice-daily ribavirin. Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label "3D". The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and follow-up phase (96 weeks) to evaluate treatment response and reinfection.
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Recruiting
Australia, New Zealand, United Kingdom
Sponsor: Kirby Institute
ClinicalTrials.gov Identifier: NCT02634008
Purpose
An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for people with recently acquired hepatitis C virus infection with or without HIV co-infection.
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Not Yet Recruiting
Sponsor: AbbVie
ClinicalTrials.gov Identifier: NCT03069365
Purpose
This Phase 3b, open-label, non-randomized study will evaluate the efficacy and safety of Glecaprevir/Pibrentasvir (GLE/PIB) for 8, 12, or 16 weeks in in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection with or without compensated liver cirrhosis and with chronic renal impairment in both HCV treatment-naïve and prior treatment-experienced participants.
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Not Yet Recruiting
United States, Puerto Rico
Sponsor: AbbVie
ClinicalTrials.gov Identifier: NCT03067129
Purpose
An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults.

Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include participants who are in 12 to < 18 years of age who can swallow the adult formulation of GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.
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Recruiting
United States, California, Australia, Belgium, Canada, France, Singapore, South Africa
Sponsor: AbbVie
ClinicalTrials.gov Identifier: NCT02966795
Purpose
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for an 8- or 12-week treatment duration in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis, who are either HCV treatment-naïve or treatment experienced with interferon (IFN) or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF plus RBV treatment-experienced).
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Recruiting
Over 20 study locations in the United States, France, Germany, Spain, Sweden
Sponsor: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02613403
Purpose
This is a randomized, multicenter, open-label trial of the combination regimen of MK-5172 (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (ruzasvir) (60 mg) for 16 weeks with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously failed a direct-acting antiviral regimen (DAA). The combination regimen will be administered as two fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily.
The study will evaluate the efficacy of the combination regimen of MK-5172 (GZR), MK-3682 and MK-8408 (ruzasvir) with or without ribavirin as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.
____________________________________________
Recruiting
United States, Texas, New Zealand
Sponsor: Merck Sharp & Dohme Corp.
Efficacy and Safety of MK-3682 + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)
ClinicalTrials.gov Identifier: NCT02956629
Purpose
This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug combination regimen (MK-3682 450 mg + ruzasvir [RZR; MK-8408] 180 mg once daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN) or treatment-experienced (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3, GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy. Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency virus (HIV) co-infection will be enrolled.
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Recruiting
United States
ClinicalTrials.gov Identifier: NCT02759315
Purpose
The study is a single-center, multiple-arm investigation of co-administration of MK-3682 450 mg and Ruzasvir (MK-8408) 60 mg in participants with chronic Hepatitis C Virus (HCV) Genotype (GT)1, GT2, GT3, GT4, GT5, or GT6. The impact of the study treatment regimen on Sustained Virologic Response (SVR)12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after ending study treatment) for each HCV Genotype will be evaluated in cirrhotic participants and non-cirrhotic participants.
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Not Yet Recruiting
Australia
Sponsor: Kirby Institute
Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs (DARLO-C)
ClinicalTrials.gov Identifier: NCT02940691
Purpose
This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use and chronic HCV genotype 1 or 4 infection.
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Not Yet Recruiting
Sponsor: Fundacion Clinic per a la Recerca Biomédica
Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients. (EGRADICATE)
ClinicalTrials.gov Identifier: NCT02890719
Purpose
Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.
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Not Yet Recruiting
France
Sponsor: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02973503
Purpose
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis
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Recruiting
Canada, Singapore, Spain, Poland, Germany, Belgium
Sponsor: Janssen Research & Development, LLC
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
ClinicalTrials.gov Identifier: NCT02765490
Purpose
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis. 
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Recruiting
New Zealand
ClinicalTrials.gov Identifier: NCT02569710
Purpose
This randomized, open-label study will assess the safety, pharmacokinetics and efficacy of the orally administered combination of AL-335, ACH-3102, and simeprevir in treatment-naïve subjects with chronic hepatitis C (CHC) infection.

This is not a complete list of clinical trials, to find out if a study is enrolling patients in your area please click here.