Clinical trials: Hepatitis C Virus
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
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic…
- Trial name
- TOPAZ-II (NCT02167945)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
- Where
- 48 sites in United States
- Volunteers
- 615 people
- Sponsor
- AbbVie
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, Chronic, Insulin Resistance
Study of Response in Chronic Hepatitis C (CHC) Participants Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (P04823/MK-4031-303)
This is a Phase 3b/4, prospective, open-label, randomized, multicenter study of peginterferon alfa-2b plus ribavirin in participants with chronic hepatitis C, genotype 1.
- Trial name
- NCT00493805
- Testing
- Combination of pegylated interferon alfa-2b and ribavirin
- Volunteers
- 59 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Safety Study of SPC3649 in Healthy Men
A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.
- Trial name
- NCT00688012
- Testing
- SPC3649
- Where
- Denmark
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Santaris Pharma A/S
Hepatitis C, Chronic
An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)
This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g.
- Trial name
- NCT01344889
- Where
- 260 sites in Albania, Algeria and 23 more
- Volunteers
- 4,459 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic, Non-Alcoholic Fatty Liver Disease
Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive.
- Trial name
- Repro (NCT01579162)
- Testing
- Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- HepQuant, LLC
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, Chronic
Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011)
To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.
- Trial name
- POMOSCH (NCT01098097)
- Testing
- Peginterferon alpha, Ribavirin
- Volunteers
- 963 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C Virus
Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)
The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in…
- Trial name
- GIFT-R (NCT02806362)
- Testing
- Ombitasvir/paritaprevir/ritonavir
- Sponsor
- AbbVie
Hepatitis C, Chronic
480 STUDY: Phase 2b Study of Locteron Plus Ribavirin to Treat Hepatitis C Virus (HCV)
The purpose of this 12-week study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic response to the 480 ug dose level of Locteron™…
- Trial name
- 480S (NCT00953589)
- Testing
- ribavirin
- Where
- 15 sites in Bulgaria, Israel and 1 more
- Volunteers
- 74 people
- Sponsor
- Biolex Therapeutics, Inc.
Hepatitis C
Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)
This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic Hepatitis C virus (HCV) infection who have not been previously treated with interferon.
- Trial name
- NCT03537274
- Testing
- PEG-Intron, Interferon Alfa-2B
- Volunteers
- 1,224 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g.
- Trial name
- NCT01447446
- Testing
- Peg-IFN Alfa-2a, Peg-IFN Alfa-2b, Ribavirin
- Where
- 271 sites in Belgium, Egypt and 25 more
- Volunteers
- 4,442 people
- Sponsor
- Hoffmann-La Roche
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
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
Chronic Hepatitis C Infection
Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir.
- Trial name
- NCT01813513
- Testing
- IDX719, Simeprevir
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without…
- Trial name
- NCT02600351
- Testing
- LDV/SOF, RBV
- Where
- 42 sites in United States, Canada and 1 more
- Volunteers
- 87 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12…
- Trial name
- NCT02097966
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 56 sites in Austria, Germany and 3 more
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients…
- Trial name
- NCT00086541
- Testing
- Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks
- Volunteers
- 515 people
- Sponsor
- Bausch Health Americas, Inc.
HCV Infection
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment
The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.
- Trial name
- NCT02402452
- Testing
- Voxilaprevir
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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