Clinical trials: Hepatitis C Infection
Hepatitis C
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and…
- Trial name
- D-LITE (NCT01309932)
- Testing
- Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor), Ribavirin (RBV)
- Where
- 40 sites in United States, Australia and 7 more
- Volunteers
- 165 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Chronic
HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
- Trial name
- NCT02806505
- Testing
- Peginterferon alfa-2a
- Where
- 22 sites in Austria, Brazil and 6 more
- Volunteers
- 81 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions
The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under fasting conditions.
- Trial name
- NCT00960479
- Testing
- Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.), Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Sandoz
Hepatitis C
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742)…
- Trial name
- NCT02251990
- Testing
- Grazoprevir/Elbasvir
- Volunteers
- 489 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)
The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness.
- Trial name
- SATISFACTION (NCT00727259)
- Testing
- Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908)
- Volunteers
- 1,995 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C Virus Infection, Genotype 1
A Phase I/II Clinical Trial With Interferon Alfa 5 in Treatment-Experienced Patients With Genotype-1 Chronic Hepatitis C
The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate the antiviral efficacy and pharmacodynamics…
- Conditions
- Chronic Hepatitis C Virus Infection, Genotype 1, Treatment-Experienced Patients, Relapses
- Trial name
- NCT01121731
- Testing
- Interferon α-5, Interferon-α5 plus Interferon-α 2b, Interferon α-2b (INTRON® A)
- Where
- 15 sites in Spain
- Volunteers
- 70 people
- Sponsor
- Digna Biotech S.L.
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic…
- Trial name
- NCT02822794
- Testing
- SOF/VEL, RBV
- Where
- 18 sites in Japan
- Volunteers
- 117 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with…
- Trial name
- NCT01628094
- Testing
- RO5024048, RO5190591, RO5466731
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
The interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in…
- Trial name
- NCT02725866
- Testing
- Paritaprevir/ritonavir/ombitasvir, Dasabuvir, Ribavirin
- Volunteers
- 216 people
- Sponsor
- AbbVie
Hepatitis C Virus
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.
- Trial name
- NCT02002767
- Testing
- Velpatasvir
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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
Hepatitis C, Viruses
TMC435-TiDP16-C107: This Study Measures the (Possible) Influence of TMC435 on the Activity of a Selected Set of Drug-degrading Proteins by Measuring the Blood Levels of Drugs That Have Been Taken Together With TMC435 and That Are Known to be Specifically Degraded by These Drug-degrading Proteins.
The purpose of this study is to determine whether TMC435 influences the activity of certain drug-degrading proteins in the human body.
- Trial name
- NCT00866853
- Testing
- TMC435
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis C, Chronic, Liver Cirrhosis
Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C…
- Trial name
- NCT00687219
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 102 people
- Sponsor
- Merck Sharp & Dohme LLC
Liver Fibrosis, Hepatic Fibrosis
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response…
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Trial name
- POLT-HCV-SVR (NCT02138253)
- Testing
- IDN-6556
- Where
- 35 sites in United States
- Volunteers
- 64 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Chronic Hepatitis C
Clinical Pharmacology Study of MP-424
To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets: Pharmacokinetics of MP-424 after a single and multiple doses.
- Trial name
- NCT01766167
- Testing
- MP-424
- Where
- South Korea
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Renal Impairment, End-stage Renal Disease
An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)
- Trial name
- NCT02397395
- Testing
- Simeprevir (SMV) 150 mg, Daclatasvir (DCV) 60 mg
- Where
- 6 sites in France, Spain
- Sponsor
- Janssen R&D Ireland
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
HCV Infection
Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers
The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.
- Trial name
- NCT00895102
- Testing
- ABT-333 Tablet, ABT-333 Capsule
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Abbott
Hepatitis C Virus Infection
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with…
- Trial name
- NCT02114151
- Testing
- Simeprevir, Sofosbuvir
- Where
- 34 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Janssen Infectious Diseases BVBA
Healthy
A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers
The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short…
- Trial name
- NCT01891851
- Testing
- TMC435350 200 mg, Ritonavir 100 mg
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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