drugset / Trial / NCT01995266

Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

NCT01995266

Phase 3 Completed 218 enrolled Bristol-Myers Squibb
NaSingle-groupOpen-labelTreatment

Summary

Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen

Timeline

Start
2014-02-28
Primary completion
2015-07-31
Completion
2015-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Asunaprevir Small molecule 100 mg Oral
Subject Daclatasvir Small molecule 60 mg Oral