Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT01492426
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients
- Detailed Description
Allocation: Randomized Stratified
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
- Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
- HCV RNA viral load ≥10,000 IU/mL
- No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
- No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
- Body mass index of 18 to 35 kg/m^2
- Negative for HIV and hepatitis B virus
Key
- Evidence of decompensated liver disease
- Evidence of medical condition other than HCV contributing to chronic liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daclatasvir + Peginterferon alfa-2a + Ribavirin Daclatasvir - Daclatasvir + Peginterferon alfa-2a + Ribavirin Peginterferon alfa-2a - Daclatasvir + Peginterferon alfa-2a + Ribavirin Ribavirin - Telaprevir + Peginterferon alfa-2a + Ribavirin Telaprevir - Telaprevir + Peginterferon alfa-2a + Ribavirin Peginterferon alfa-2a - Telaprevir + Peginterferon alfa-2a + Ribavirin Ribavirin -
- Primary Outcome Measures
Name Time Method Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Week 12 (Follow-up period) SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
- Secondary Outcome Measures
Name Time Method Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4 Week 4 RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12 Week 4, Week 12 eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Week 12 (Follow-up period) SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR) Week 12 cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24) Week 24 (Follow-up period) SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.
Trial Locations
- Locations (26)
The Kirklin Clinic
🇺🇸Birmingham, Alabama, United States
Atlanta Medical Center
🇺🇸Atlanta, Georgia, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Va Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Gastrointestinal Specialists Of Georgia
🇺🇸Marietta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University Of Maryland
🇺🇸Baltimore, Maryland, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Minnesota Gastroenterology, P.A.
🇺🇸Saint Paul, Minnesota, United States
Saint Louis University Gastroenterology & Hepatology
🇺🇸St. Louis, Missouri, United States
University Of North Carolina At Chapel Hill School Of Med
🇺🇸Chapel Hill, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College Of Medicine
🇺🇸Houston, Texas, United States
Research Specialists Of Texas
🇺🇸Houston, Texas, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Brooke Army Medical Center
🇺🇸Ft. Sam Houston, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Local Institution
🇬🇧Birmingham, West Midlands, United Kingdom
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States