Clinical trials: Chronic HCV Infection
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
PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)
This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and…
- Trial name
- NCT01070550
- Testing
- Peginterferon alfa-2a (Pegasys®)
- Where
- 266 sites in Austria, Brazil and 12 more
- Volunteers
- 4,680 people
- Sponsor
- Hoffmann-La Roche
Liver Transplantation, Hepatitis C, Chronic
Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)
This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at…
- Conditions
- Liver Transplantation, Hepatitis C, Chronic, Liver Cirrhosis
- Trial name
- NCT00378599
- Testing
- Combination of (a) pegylated interferon alfa-2b and (b) rebetol
- Volunteers
- 125 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV, Hepatitis C, Chronic
The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
The purpose of this research study is to explore what role immune cells within the gut (the sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or HCV/ HIV co-infection.
- Conditions
- HIV, Hepatitis C, Chronic, HCV Coinfection
- Trial name
- NCT01335230
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
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
ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.
This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy.
- Trial name
- NCT00077636
- Testing
- Copegus, peginterferon alfa-2a [Pegasys]
- Where
- 132 sites in United States, Australia and 7 more
- Volunteers
- 1,469 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic, Substance Abuse, Intravenous
Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)
Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling.
- Trial name
- SUPPORT (NCT00726557)
- Testing
- PegIntron (pegylated interferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 246 people
- Sponsor
- Merck Sharp & Dohme LLC
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, Hepatitis C
Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)
Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment.
- Trial name
- NCT00725205
- Testing
- PegIntron (Peginterferon alfa-2b), Rebetol (Ribavirin)
- Volunteers
- 294 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
Hepatitis C Virus Infection
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic…
- Trial name
- NCT02671500
- Testing
- SOF/VEL
- Where
- 38 sites in China, Malaysia and 3 more
- Volunteers
- 375 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)
This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.5/R (24 weeks)], compared to a lower…
- Trial name
- NCT00302081
- Testing
- peginterferon alfa-2b (SCH 54031), ribavirin (SCH 18908)
- Volunteers
- 696 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
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
Kidney Failure, Hepatitis C
QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir
This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor…
- Conditions
- Kidney Failure, Hepatitis C, Kidney Disease, Chronic
- Trial name
- QUICK-CURE (NCT04515797)
- Testing
- Glecaprevir and Pibrentasvir
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Massachusetts General Hospital
Chronic Hepatitis C
PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.
- Trial name
- NCT00100659
- Testing
- Pegylated Interferon/ribavirin
- Where
- 11 sites in United States
- Volunteers
- 114 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis C Virus Infection
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus…
- Trial name
- NCT02300103
- Testing
- SOF/VEL, RBV
- Where
- 30 sites in United States, Australia and 2 more
- Volunteers
- 69 people
- Sponsor
- Gilead Sciences
Adult Primary Liver Cancer, Hepatitis C Infection
Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection
This randomized phase II trial studies how well S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) works compared to a placebo in preventing liver cancer in patients with chronic hepatitis C infection.
- Trial name
- NCT00513461
- Testing
- S-adenosyl-L-methionine disulfate p-toluene-sulfonate, laboratory biomarker analysis, immunoenzyme technique
- Where
- 5 sites in United States
- Volunteers
- 110 people
- Sponsor
- Chao Family Comprehensive Cancer Center
Hepatitis C, Chronic
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons.
- Trial name
- NCT01054573
- Testing
- Telaprevir, pegylated interferon (Peg-IFN) alfa-2a, ribavirin (RBV)
- Where
- 48 sites in United States, Australia and 13 more
- Volunteers
- 90 people
- Sponsor
- Janssen Infectious Diseases BVBA