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.
The clinical trials listed on this page can be found online at 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 and search by Country.

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.

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 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) 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 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 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: RBV 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 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 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 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 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 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 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'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 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 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 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.

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 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 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.

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.

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