Safety and Efficacy Study of Peginterferon Lambda-1a With and Without Daclatasvir, Compared to Peginterferon Alfa-2, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
- Conditions
- Chronic HCV GT-2 and -3
- Registration Number
- JPRN-jRCT2080221960
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 875
Compensated cirrhotic and non-cirrhotic subjects who are naive to prior anti-HCV therapy, and have chronic HCV GT-2 or- 3 infection with HCV RNA viral load greater than or equal to 100,000 IU/mL. For Japan, compensated and non-compensated cirrhotics will NOT be included in this study.
Infected with HCV other than Genotype 2 or 3.
Evidence of medical condition associated with chronic liver disease other than HCV.
Positive HBsAg, or HIV-2/HIV-2 antibody at screening.
Active substance abuse (eg, alcohol, inhaled/injected drugs) within 6 months prior to screening.
Use of hematologic growth factors within 90 days prior to randomization.
Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method