ITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C
Phase 3
- Conditions
- Hepatitis C Virus Infection
- Registration Number
- JPRN-jRCT2080222495
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 286
Inclusion Criteria
Males and females, at least 20 years of age
Subjects chronically infected with HCV GT-1
HCV RNA viral load of not less than 100,000 IU/m
Exclusion Criteria
Hepatocellular carcinoma
Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
Severe or uncontrollable complication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA less than LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12 [ Time Frame: After 12 weeks of the last dose ] [ Designated as safety issue: No ]
- Secondary Outcome Measures
Name Time Method