Clinical trials: Chronic Hepatitis
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 B, Chronic, Chronic Hepatitis B
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814.
- Trial name
- NCT00403585
- Testing
- adefovir dipivoxil 10mg
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
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
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
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 B
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents.
- Trial name
- NCT02479880
- Testing
- Tenofovir DF, DEXA Scan
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
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 B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
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
Hepatitis B, Chronic
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
- Trial name
- DEFINE (NCT00410202)
- Testing
- Entecavir, Tenofovir, Adefovir
- Where
- 67 sites in United States, Australia and 16 more
- Volunteers
- 629 people
- Sponsor
- Bristol-Myers Squibb