A study to assess thedurability of sustained virologic response in Alisporivirtreatedchronic Hepatitis C patients
Phase 3
- Conditions
- Health Condition 1: null- chronic Hepatitis C
- Registration Number
- CTRI/2012/10/003066
- Lead Sponsor
- ovartis Healthcare Pvt Lt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 2000
Inclusion Criteria
1. Written informed consent must be obtained before any assessment is performed.
3. Have previously completed a Novartis-sponsored hepatitis C study and received
alisporivir
4. Have achieved SVR24
5. Are able to comply with the visit schedule
Exclusion Criteria
1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of
that medication, whichever is longer.
2. Use or planned use to start a new course of hepatitis C therapy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the durability of sustained virologic response after SVR24 has been <br/ ><br>achieved in patients treated with alisporivir in a Novartis-sponsored chronic Hepatitis <br/ ><br>C studyTimepoint: Nil
- Secondary Outcome Measures
Name Time Method 1. To determine whether subsequent detection of HCV RNA in patients who relapse <br/ ><br>following SVR24, represents the re-emergence of pre-existing virus, the development <br/ ><br>of resistance mutations, or whether it is due to re-infection <br/ ><br>2. To assess the impact of successful alisporivir treatment on the change in liver disease <br/ ><br>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: Nil