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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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This study is currently recruiting participants
Australia
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.
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.
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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.
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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.
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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.
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This study is currently recruiting participants
India
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only)
Drug: elbasvir/grazoprevir
Drug: Dasabuvir
This is not a complete list of clinical trials, to find out if a study is enrolling patients in your area please click here.
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.
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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
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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This study is currently recruiting participants
Sponsor: University of Florida
45 study locations in the United States
Sponsor: University of Florida
Study of Oral Treatments for Hepatitis C (PRIORITIZE)
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/ledipasvirDrug: ombitasvir/paritaprevir/ritonavir (Phase 1 only)
Drug: elbasvir/grazoprevir
Drug: Dasabuvir
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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.
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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.
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Expanded access is currently available for this treatment.
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com
Expanded Access to Glecaprevir/ Pibrentasvir
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
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.
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This study is not yet open for participant recruitment
France
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
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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
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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).
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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.
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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)
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 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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