NCT01428063

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

Detailed description

* Intervention Model: * Parallel: for all patients entering the trial * Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study * Peginterferon alfa-2a * Ribavirin * Daclatasvir * Asunaprevir

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	Daclatasvir
DRUG	Asunaprevir
DRUG	Pegylated interferon alfa-2a
DRUG	Ribavirin

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2011-09-02
• Last updated: 2016-05-27
• Results posted: 2016-05-27

Locations

106 sites across 19 countries: United States, Argentina, Australia, Austria, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, New Zealand, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom