Clinical trials: Hepatitis C, Chronic
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects…
- Trial name
- ION-2 (NCT01768286)
- Testing
- LDV/SOF, RBV
- Where
- 53 sites in United States
- Volunteers
- 441 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120…
- Trial name
- NCT01830127
- Testing
- Ribavirin, BI 207127 high dose, Faldaprevir
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 35 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C
Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
The purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in…
- Trial name
- NCT01508286
- Testing
- Telaprevir + peginterferon alfa + ribavirin, peginterferon alfa + ribavirin
- Where
- 128 sites in Australia, Austria and 13 more
- Sponsor
- Janssen-Cilag International NV
Hepatitis C Virus
Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit…
- Trial name
- Hallmark DUAL (NCT01581203)
- Testing
- Asunaprevir (ASV), Daclatasvir (DCV), Pegylated-interferon alfa 2a (PegIFN)
- Where
- 116 sites in United States, Argentina and 16 more
- Volunteers
- 748 people
- Sponsor
- Bristol-Myers Squibb
Healthy, Hepatitis C, Chronic
A Study to Evaluate the Safety, Tolerability, and PK in Healthy Volunteers and HCV Genotype 1 Infected Patients
A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1 Infected Patients
- Trial name
- NCT01523990
- Testing
- TG-2349
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- TaiGen Biotechnology Co., Ltd.
Chronic Hepatitis C
Evaluating Fine Needle Aspiration to Measure Hepatic Vaniprevir (MK-7009) Concentrations in Participants With Chronic Hepatitis C (MK-7009-048)
This study will evaluate the technical feasibility of using fine needle aspiration (FNA) of liver tissue to obtain vaniprevir (MK-7009) liver pharmacokinetic (PK) data, working towards identifying a minimally invasive…
- Trial name
- NCT01678131
- Testing
- Vaniprevir 600 mg, Peg-IFN alfa-2b, Ribavirin
- Volunteers
- 31 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)
The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.
- Trial name
- NCT01907724
- Testing
- IDX719, Simeprevir, TMC647055
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1)
This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.
- Trial name
- ECLIPSE 1 (NCT01025596)
- Testing
- Interleukin-7
- Where
- 7 sites in France, Italy and 1 more
- Volunteers
- 10 people
- Sponsor
- Cytheris SA
Hepatitis C, Chronic
A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys…
- Trial name
- NCT01185860
- Testing
- danoprevir, peginterferon alfa-2a [Pegasys], ribavirin
- Where
- 4 sites in France, New Zealand and 1 more
- Volunteers
- 59 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C.
- Trial name
- NCT00104052
- Testing
- peginterferon alfa-2b (PEG2b) (SCH 54031), ribavirin (SCH 18908)
- Volunteers
- 107 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1
This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients…
- Trial name
- NCT01750216
- Where
- 14 sites in Poland
- Volunteers
- 196 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.
- Trial name
- NCT01466192
- Testing
- MP-424 (generic name:Telaprevir), Ribavirin, Peginterferon alfa-2b
- Where
- Japan
- Volunteers
- 108 people
- Sponsor
- Tanabe Pharma Corporation
Chronic HCV Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis…
- Trial name
- NCT02120300
- Testing
- LDV/SOF, SOF, RBV
- Where
- 13 sites in United States
- Volunteers
- 122 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients…
- Trial name
- NCT01331850
- Testing
- Copegus, Pegasys, RO5024048
- Where
- 67 sites in United States, Australia and 11 more
- Volunteers
- 381 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Liver Disease
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e.
- Trial name
- NCT01970904
- Testing
- Alisporivir, Ribavirin, Peg-IFNα2a
- Where
- 25 sites in Germany, Poland and 2 more
- Volunteers
- 147 people
- Sponsor
- Debiopharm International SA
Hepatitis, Hepatitis C
An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.
- Trial name
- NCT01889433
- Testing
- Algeron, Pegasys
- Where
- 19 sites in Belarus, India and 2 more
- Volunteers
- 170 people
- Sponsor
- Biocad
Chronic Hepatitis C Infection, Genotype 1
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.
- Trial name
- NCT01194037
- Testing
- recombinant variant of interferon-alpha 2b, Peginterferon alfa-2a, Ribavirin
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- HanAll BioPharma Co., Ltd.
Hepatitis C, Chronic
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.
This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups.
- Trial name
- NCT00517439
- Testing
- Copegus, Pegasys, RO4588161
- Where
- 63 sites in United States, Australia and 7 more
- Volunteers
- 516 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
This randomized, cross-over, open label study will compare the tolerability and handling of application of peginterferon alfa-2a [Pegasys] by autoinjector versus pre-filled syringe in patients with chronic hepatitis C, either on…
- Trial name
- NCT01087944
- Testing
- Autoinjector, Pre-filled syringe
- Where
- 12 sites in United States
- Volunteers
- 60 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, HIV Infections
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV…
- Trial name
- NCT00983853
- Testing
- peginterferon alfa-2a, ribavirin (fixed dose), ribavirin (weight-based dose)
- Where
- 16 sites in United States, France and 2 more
- Volunteers
- 62 people
- Sponsor
- Vertex Pharmaceuticals Incorporated