Chronic Hepatitis C Virus Infection registry to understand the Chronic Hepatitis C Virus Infectio
Not Applicable
- Conditions
- Health Condition 1: B182- Chronic viral hepatitis C
- Registration Number
- CTRI/2018/12/016505
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients of either sex aged >=18 years
Patients considered eligible for treatment with DAAs, as per the approved prescribing
information
Patients willing to provide a completed and signed written consent prior to initiation
of treatment
Exclusion Criteria
Concurrent participation in a HCV clinical trial (except trials not testing investigational
medicinal products)
Patient with a risk of uncertainty regarding returning for follow-up (e.g., patients
planning to move or leave the country in a foreseeable future)
Pregnant or nursing (lactating) women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of HCV genotypes, and patterns of anti-HCV treatment strategies in <br/ ><br>different countriesTimepoint: 12 months
- Secondary Outcome Measures
Name Time Method Sustained virologic response at 12 and/or 24 weeks after the end of the treatment <br/ ><br>with DAA regimens (SVR12 and/or SVR24) <br/ ><br>Improvement in hepatic encephalopathy, ascites, gastrointestinal bleeding, <br/ ><br>Proportion of participants who need liver transplantation <br/ ><br>Number of liver-related deaths during and/or after the treatment <br/ ><br>Incidence of adverse events with various DAA treatment regimens <br/ ><br>Proportion of participants with virologic failureTimepoint: 12 months