Chronic Hepatitis C
Conditions
Interventions
investigational material(s)
Generic name etc : Asunaprevir(BMS-650032), Daclatasvir(BMS-790052)
INN of investigational material :
Therapeutic category code : 625 Anti-virus agents
Dosage and Administ
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must have received at least one dose of BMS-650032 and/or BMS-790052 and completed participation in a previous study - Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability
Exclusion criteria
Exclusion criteria: - Subject must not have been treated with any antiviral or immunomodulatory drug for CHC after completion of the previous study - Subject must not be participating in any other trial, xcluding non-interventional trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The durability of virologic response Measuremant of HCV RNA | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the presence of HCV sequence variants over time - To characterize the long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all-cause mortality, and liver-related mortality, - Viral resistance test(s) - Liver function tests etc. | — |
Outcome results
None listed