January 2017 Update - Recruiting and upcoming hepatitis C clinical trials

Sunday, January 15, 2017

January 2017 Update - Recruiting and upcoming hepatitis C clinical trials

Recruiting and upcoming hepatitis C clinical trials

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 clinical trials, to find out if a study is enrolling patients in your area please click here.

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.

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.

Sponsor:

This study is currently recruiting participants
United States, Texas, New Zealand
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.

Condition	Intervention	Phase
Hepatitis C	Drug: MK-3682 Drug: Ruzasvir Drug: Ribavirin	Phase 2

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Sponsor:

This study is currently recruiting participants
United States
Efficacy and Safety of MK-3682 With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)

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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: MK-3682 450 mg Drug: Ruzasvir 60 mg

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Collaborators:

Patient-Centered Outcomes Research Institute

Merck Sharp & Dohme Corp.

AbbVie

This study is currently recruiting participants
45 Study Locations United States
Study of Oral Treatments for Hepatitis C (PRIORITIZE)

ClinicalTrials.gov Identifier:

NCT02786537

Purpose

The study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. 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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: sofosbuvir/ledipasvir Drug: ombitasvir/paritaprevir/ritonavir Drug: elbasvir/grazoprevir Drug: Dasabuvir	Phase 4

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Sponsor:

This study is currently recruiting participants

United States, Maryland

Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816

ClinicalTrials.gov Identifier:

NCT02468648

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: Sofosbuvir Drug: GS-5816

_________________________________________

Sponsor:

This study is currently recruiting participants
Australia, New South Wales
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

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.

Condition	Intervention	Phase
Hepatitis C	Drug: Sofosbuvir (SOF)/GS-5816	Phase 2

_________________________________________

Sponsor:

Some locations recruiting participants
40 Study Locations China Malaysia Singapore Thailand Vietnam
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

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.

Condition	Intervention	Phase
Hepatitis C Virus Infection	Drug: SOF/VEL	Phase 3

_________________________________________

Sponsor:

Collaborators:

Unity Health Care, Inc.

Gilead Sciences

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 (RESOLVE)

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: Sofosbuvir/Velpatasvir/GS-9857	Phase 2

_________________________________________

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

This study is currently recruiting participants
United States
12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF

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.

Condition	Intervention	Phase
HIV-1 Infection Hepatitis C	Drug: Ledipasvir/sofosbuvir Drug: Ribavirin

_________________________________________

Sponsor:

This study is currently recruiting participants
United States
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.

Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study

Condition	Intervention	Phase
Hepatitis C	Drug: Sofosbuvir/Ledipasvir x 8 weeks Drug: Sofosbuvir/Ledipasvir x 12 weeks Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks	Phase 4

_________________________________________

Sponsor:

Most locations recruiting participants
51 Study Locations United States Australia Belgium India Italy New Zealand United KingdomSafety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

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.

Condition	Intervention	Phase
Hepatitis C Virus Infection	Drug: SOF (oral tablets) Drug: RBV Drug: SOF (oral granules)	Phase 2

_________________________________________

Sponsor:

This study is currently recruiting participants
34 Study Locations United States United Kingdom New Zealand Australia United Kingdom
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.

Condition	Intervention	Phase
Hepatitis C Virus Infection	Drug: LDV/SOF Drug: Placebo to match LDV/SOF Drug: RBV	Phase 2

_________________________________________

Sponsor:

This study is currently recruiting participants
United States, 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

Condition	Intervention	Phase
Genotype 1 Hepatitis C Virus	Drug: harvoni	Phase 4

_________________________________________

Sponsor:

Collaborator:

AbbVie

This study is currently recruiting participants
United Kingdom, New Zealand, Australia

Treatment of Recently Acquired Genotype 1 Hepatitis C With the 3D Regimen

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.

Condition	Intervention	Phase
Hepatitis C, Acute	Drug: Paritaprevir/ritonavir/ombitasvir Drug: Dasabuvir Drug: Ribavirin	Phase 4

_________________________________________

Sponsor:

This study is currently recruiting participants
33 Study Locations United States
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy

ClinicalTrials.gov Identifier:

NCT02194998

Purpose

HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and routes of transmission. For this reason, many people infected with HIV are also infected with HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose of this study is to evaluate the safety, tolerability, and effectiveness of IFN-free HCV treatment in HIV/HCV coinfected adults who are taking antiretroviral (ARV) therapy.

Condition	Intervention	Phase
HIV Infections	Drug: Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT) Drug: Dasabuvir (DSV) Drug: Ribavirin (RBV)	Phase 2

_________________________________________

Sponsor:

This study is currently recruiting participants
Australia, New South Wales
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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: "3D" regimen Drug: "3D" regimen with ribavirin

________________________________________

Sponsor:

This study is not yet open for participant recruitment
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).

Condition	Intervention	Phase
Chronic Hepatitis C Virus Genotype 5 or 6 Infection	Drug: Glecaprevir/Pibrentasvir	Phase 3

_________________________________________

Sponsor:

This study is currently recruiting participants
26 Study Locations United States Canada United Kingdom Switzerland Spain Puerto Rico Germany Belgium
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

ClinicalTrials.gov Identifier:
NCT02486406
Purpose
The purpose of this three part study is to evaluate the pharmacokinetics (Part 1), safety/efficacy (Part 2), and long-term follow-up (Part 3) of ombitasvir (OBV), paritaprevir (PTV), ritonavir (RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in pediatric subjects with genotype 1 or 4 chronic hepatitis C virus (HCV) infection.

Condition	Intervention	Phase
Chronic Hepatitis C Infection	Drug: ombitasvir Drug: paritaprevir Drug: ritonavir Drug: dasabuvir Drug: ribavirin

________________________________________

Sponsor:

This study is not yet open for participant recruitment

Australia
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.

Arms	Assigned Interventions
Experimental: Grazoprevir/elbasvir Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.	Drug: Grazoprevir/elbasvir Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks. Other Name: Zepatier

________________________________________

Sponsor:

This study is not yet open for participant recruitment
Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients

ClinicalTrials.gov Identifier:

NCT02897596

Purpose

Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.

Condition	Intervention	Phase
Hepatitis C HIV	Drug: Grazoprevir 100 mg/d 8 weeks Drug: Elbasvir 50 mg/d 8 weeks Drug: Grazoprevir 100 mg/d 12 weeks Drug: Elbasvir 50 mg/d 12 weeks

_________________________________________

Sponsor:

Some locations - recruiting participants
Canada Singapore Spain Poland Germany Belgium
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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: AL-335 Drug: Odalasvir Drug: Simeprevir

_________________________________________

Sponsor:

This study is currently recruiting participants
New Zealand
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, ACH-3102, and Simeprevir

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: AL-335 Drug: ACH-3102 Drug: Simeprevir

This is not a complete list of clinical trials, to find out if a study is enrolling patients in your area please click here.
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Sunday, January 15, 2017

January 2017 Update - Recruiting and upcoming hepatitis C clinical trials

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