A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy versus Telaprevir Therapy in Japanese HCV subjects.
Phase 3
- Conditions
- Hepatitis C virus infection
- Registration Number
- JPRN-jRCT2080221958
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 224
Inclusion Criteria
chronic HCV-1b infected patient
- HCV RNA > 100,000 IU/mL at screening
- ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort),
- Treatment naive subjects to IFN based therapy
- Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up.
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 proportion of SVR12 (below LLOQ) at post treatment week12 in naive cohort
- Secondary Outcome Measures
Name Time Method - To compare proportion of hemoglobin decreased<br>- To compare the proportion of rash related event.<br>- To assess anti-viral activity in naive cohort<br>- To assess anti-viral activity in relapser cohort<br>- To assess safety