A phase 3 Study of BMS-790052 plus BMS-650032 combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects
Phase 3
- Conditions
- Chronic Hepatitis C
- Registration Number
- JPRN-jRCT2080221687
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
chronic HCV-1b infected patient
- HCV RNA >= 100,000 IU/mL at screening
- non-responder to interferon plus ribavirin therapy
- patient who has been excluded from interferon/ribavirin therapy or intolerant for interferon/ribavirin therapy
Exclusion Criteria
Patients who have;
- hepatocellular carcinoma
- co-infection with HBV or HIV
- severe or uncontrollable complication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess antiviral activity, as determined by the proportion of subjects with SVR.
- Secondary Outcome Measures
Name Time Method - To assess safety<br>- To assess the antiviral activity, as determined by the proportion of subjects who acheive undetectable (or below LOQ) HCV RNA at each scheduled visit. <br>- To assess the relationship between efficacy and the single nucleotide polymorphisms (SNPs) in the IL28B gene