Clinical trials: Genotype 1 Chronic Hepatitis C
Hepatitis C Infection With HIV Co-Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT02457611
- Testing
- LDV/SOF
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
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…
- Trial name
- NCT02765490
- Testing
- AL-335, Odalasvir, Simeprevir
- Where
- 28 sites in Belgium, Canada and 4 more
- Volunteers
- 365 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis C
Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve…
- Trial name
- NCT01579474
- Testing
- BI 201335 high dose, BI 201335 low dose
- Where
- 24 sites in Japan
- Volunteers
- 131 people
- Sponsor
- Boehringer Ingelheim
Chronic Hepatitis C Infection
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV)…
- Trial name
- NCT01260350
- Testing
- SOF, RBV, PEG
- Where
- 2 sites in New Zealand
- Volunteers
- 292 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1
This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1.
- Trial name
- NCT01508130
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 672 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C
A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment…
- Trial name
- NCT01330316
- Testing
- BI 201335, PegIFN/RBV
- Where
- 87 sites in United States, Austria and 13 more
- Volunteers
- 119 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C Virus
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or…
- Trial name
- ACCORDION-1 (NCT02349048)
- Testing
- Simeprevir 150 mg, Daclatasvir 60 mg, Sofosbuvir 400 mg
- Where
- 8 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis C, Chronic
A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to…
- Trial name
- NCT01288209
- Testing
- TMC435, Peginterferon alfa-2a (PegIFNα-2a ), Ribavirin (RBV)
- Where
- 19 sites in Japan
- Volunteers
- 106 people
- Sponsor
- Janssen Pharmaceutical K.K.
Hepatitis C, Chronic
Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)
This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult subjects with chronic hepatitis C (CHC) genotype…
- Trial name
- NCT00708500
- Testing
- Boceprevir (SCH 503034), Pegylated interferon alfa-2b (SCH 54031), Ribavirin (SCH 18908)
- Volunteers
- 404 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral…
- Trial name
- NCT00423800
- Testing
- Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
- Volunteers
- 56 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C
An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062)
This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the treatment of chronic HCV GT1, GT4, or GT6…
- Trial name
- C-EDGE CO-STAR (NCT02105688)
- Testing
- Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A)
- Volunteers
- 301 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
- Trial name
- NCT00336479
- Testing
- Telaprevir, Ribavirin, Pegylated Interferon Alfa 2a
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 263 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis C
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
- Trial name
- NCT00780416
- Testing
- MP-424, Ribavirin, Peginterferon Alfa-2b
- Where
- Japan
- Volunteers
- 189 people
- Sponsor
- Tanabe Pharma Corporation
Hepatitis C, Chronic
Efficacy and Safety of Uprifosbuvir (MK-3682) With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)
This study is an open-label, multi-center trial to evaluate the novel 2-drug regimen of uprifosbuvir (MK-3682) 450 mg and ruzasvir (MK-8408) 60 mg in participants with chronic hepatitis C virus (HCV) genotype (GT)1, GT2, GT3…
- Trial name
- NCT02759315
- Testing
- Uprifosbuvir 450 mg, Ruzasvir 60 mg
- Volunteers
- 160 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 …
- Trial name
- MAGELLAN-3 (NCT02939989)
- Testing
- Sofosbuvir, Glecaprevir/Pibrentasvir, Ribavirin
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 33 people
- Sponsor
- AbbVie
Chronic Hepatitis C
A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection
- Trial name
- NCT00546715
- Testing
- Daclatasvir
- Where
- 7 sites in United States
- Volunteers
- 95 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs
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…
- Trial name
- DARLO-C (NCT02940691)
- Testing
- Grazoprevir/elbasvir
- Where
- 5 sites in Australia
- Volunteers
- 32 people
- Sponsor
- Kirby Institute
Hepatitis C, Chronic
Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the…
- Trial name
- CONCISE (NCT01459913)
- Testing
- Telaprevir, Pegylated Interferon Alfa-2a, Ribavirin
- Where
- 83 sites in United States, Austria and 4 more
- Volunteers
- 239 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis C Virus Infection
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic…
- Trial name
- NCT02378935
- Testing
- VOX, SOF/VEL, RBV
- Where
- 34 sites in United States, New Zealand and 1 more
- Volunteers
- 205 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection.
- Trial name
- NCT00774397
- Testing
- BI 201335 NA 240 mg QD / LI, PegIFN/RBV, BI 201335 NA 120mg QD / LI
- Where
- 100 sites in United States, Argentina and 13 more
- Volunteers
- 719 people
- Sponsor
- Boehringer Ingelheim