Clinical trials: Hepatitis C, Chronic
Hepatitis C
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN…
- Trial name
- ATTAIN (NCT01485991)
- Testing
- TMC435, TVR
- Where
- 137 sites in United States, Argentina and 22 more
- Volunteers
- 771 people
- Sponsor
- Janssen R&D Ireland
Chronic Hepatitis C Infection
Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants
The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.
- Trial name
- NCT01700179
- Testing
- ACH-0143102, Ribavirin
- Volunteers
- 8 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatitis C, Chronic, Hepacivirus
Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which…
- Trial name
- NCT00723879
- Testing
- Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908), Patient assistance program
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC…
- Trial name
- NCT00377182
- Testing
- Copegus, PEGASYS, RO5024048 1500mg
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 107 people
- Sponsor
- Hoffmann-La Roche
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, Hepatitis C, Chronic
Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)
The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment.
- Trial name
- NCT00724451
- Testing
- Peginterferon alfa-2b, Ribavirin, Peginterferon alfa-2a
- Volunteers
- 1,128 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus…
- Trial name
- NCT00394277
- Testing
- peginterferon alfa-2a, Ribavirin
- Where
- 184 sites in United States, Belgium and 13 more
- Volunteers
- 1,175 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients
The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects
- Trial name
- NCT01525212
- Testing
- BMS-929075
- Where
- 3 sites in Australia
- Sponsor
- Bristol-Myers Squibb
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
Chronic Hepatitis C, CHC
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C, CHC, HCV, Hepatitis C
- Trial name
- NCT01842451
- Testing
- VX-135, Daclatasvir
- Where
- 2 sites in New Zealand
- Volunteers
- 23 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis C
Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects
This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in…
- Trial name
- INH-189-006 (NCT01445795)
- Testing
- 200 mg INX-08189 Fasted, 100 mg INX-08189 QD, 100 mg INX-08189 with low-fat meal
- Where
- 2 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C
Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment…
- Trial name
- NCT01455090
- Testing
- BMS-650032, BMS-790052, BMS-791325
- Where
- 32 sites in United States, France and 1 more
- Volunteers
- 320 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Chronic, Hepatitis C
Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults.
- Trial name
- NCT00439959
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC…
- Trial name
- NCT00353418
- Testing
- Peginterferon alfa-2a, Ribavirin
- Volunteers
- 415 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients
This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with…
- Trial name
- NCT02118597
- Testing
- Boceprevir, Simeprevir, Pegylated Interferon (Peginterferon) Alfa-2a
- Where
- 7 sites in Hungary
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C Virus Infection
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women…
- Trial name
- NCT02114177
- Testing
- Simeprevir, Sofosbuvir
- Where
- 40 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Janssen Infectious Diseases BVBA
Hepatitis C, Chronic
A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy
In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be…
- Trial name
- NCT01337375
- Testing
- peginterferon alfa 2a [Pegasys], peginterferon alfa-2a [Pegasys]
- Where
- 5 sites in Germany
- Volunteers
- 31 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C
This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C.
- Trial name
- NCT00800748
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 35 sites in Czechia, Slovakia
- Volunteers
- 372 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) in Japanese participants with…
- Trial name
- NCT01405560
- Testing
- Vaniprevir, peg-IFN, ribavirin
- Volunteers
- 42 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis…
- Trial name
- ASTRAL-1 (NCT02201940)
- Testing
- SOF/VEL
- Where
- 80 sites in United States, Belgium and 7 more
- Volunteers
- 741 people
- Sponsor
- Gilead Sciences