drugset / Trial / NCT01718145

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

NCT01718145

Phase 3 Completed 258 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject. The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects

Timeline

Start
2012-11
Primary completion
2013-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Asunaprevir Small molecule 200 mg Oral
Subject Daclatasvir Small molecule 60 mg Oral
Comparator Telaprevir Small molecule 750 mg Oral
Comparator Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg Subcutaneous
Comparator Ribavirin Small molecule 600 mg Oral
Comparator Ribavirin Small molecule 1000 mg Oral