NCT01718145

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

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	Daclatasvir
DRUG	Asunaprevir
DRUG	Ribavirin
BIOLOGICAL	pegIFNα-2b
DRUG	Telaprevir

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2012-10-31
• Last updated: 2015-10-09

Locations

48 sites across 1 country: Japan