Health Condition 1: B182- Chronic viral hepatitis C
Conditions
Interventions
None listed
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of HCV genotypes, and patterns of anti-HCV treatment strategies in different countriesTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained virologic response at 12 and/or 24 weeks after the end of the treatment with DAA regimens (SVR12 and/or SVR24) Improvement in hepatic encephalopathy, ascites, gastrointestinal bleeding, Proportion of participants who need liver transplantation Number of liver-related deaths during and/or after the treatment Incidence of adverse events with various DAA treatment regimens Proportion of participants with virologic failureTimepoint: 12 months | — |
Countries
Belarus, Burkina Faso, Cameroon, India, Indonesia, Kazakhstan, Malaysia, Myanmar, Namibia, Nigeria, Philippines, Thailand, Ukraine, Uzbekistan, Zimbabwe
Contacts
Public ContactDr Sanjay Hadigal
Mylan Pharmaceuticals Private Limited
Outcome results
None listed