A study to assess the viralactivity in patients who failed to achieve sustainedvirologic response in Novartis-sponsored DEB025A2211 (CTRI - CTRI/2010/091/002967)
Phase 3
Completed
- Conditions
- Health Condition 1: null- chronic Hepatitis C
- Registration Number
- CTRI/2012/10/003061
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 650
Inclusion Criteria
1.Written informed consent must be obtained before any assessment is performed.
2.Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or
a direct antiviral agent.
3.Have not achieved SVR24.
Exclusion Criteria
1.Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of thatmedication, whichever is longer.
2.Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored
hepatitis C study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the persistence of resistance associated variants associated with failure to <br/ ><br>previous alisporivir therapyTimepoint: N/A
- Secondary Outcome Measures
Name Time Method 1.To perform phenotypic analysis of HCV isolates to determine the patients <br/ ><br>susceptibility/resistance to alisporivir in vitro <br/ ><br>2.To monitor the changes in liver function and disease over time <br/ ><br>3. To assess the development of hepatocellular carcinoma (HCC) <br/ ><br>4.To assess the safety over time of previous alisporivir exposureTimepoint: N/A