A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
- Conditions
- Chronic Hepatitis C Virus Genotype 1
- Interventions
- Registration Number
- NCT01142700
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Treatment-naive subjects with genotype 1 chronic HCV
- HCV RNA ≥ 100,000 IU/mL at screening
- Seronegative for HIV and HBsAg
- Liver biopsy within prior 2 years demonstrating no cirrhosis
- Any evidence of liver disease other than hepatitis C
- Diagnosed or suspected hepatocellular carcinoma
- Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
- Cirrhosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-824393 (30 mg) Ribavirin Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 BMS-824393 (10mg) BMS-824393 Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 BMS-824393 (10mg) Peginterferon Alpha-2a Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 BMS-824393 (30 mg) BMS-824393 Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 BMS-824393 (30 mg) Peginterferon Alpha-2a Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 BMS-824393 (100 mg) BMS-824393 Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 BMS-824393 (100 mg) Peginterferon Alpha-2a Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 Placebo Placebo Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 Placebo Peginterferon Alpha-2a Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 Peginterferon alfa-2a plus Ribavirin Peginterferon Alpha-2a Weeks 13 - 48 Peginterferon alfa-2a plus Ribavirin Ribavirin Weeks 13 - 48 BMS-824393 (10mg) Ribavirin Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 BMS-824393 (100 mg) Ribavirin Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 Placebo Ribavirin Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12
- Primary Outcome Measures
Name Time Method Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) Week 48 Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA Week 12
- Secondary Outcome Measures
Name Time Method Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA Week 4 Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA Week 12 Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable Week 24 (SVR24) Resistant variants associated with virologic failure Week 24
Trial Locations
- Locations (10)
Local Institution
🇺🇸Philadelphia, Pennsylvania, United States
Research And Education, Inc.
🇺🇸San Diego, California, United States
Gastrointestinal Specialists Of Georgia Pc
🇺🇸Mareitta, Georgia, United States
Maryland Digestive Disease Research
🇺🇸Laurel, Maryland, United States
Bach And Godofsky Infectious Diseases
🇺🇸Bradenton, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Vita Medical Center & Research Solutions, Inc.
🇺🇸Tamarac, Florida, United States
Liver Institute Of Virginia Bon Secours Health System
🇺🇸Newport News, Virginia, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States