NCT00874770

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

Conditions

• Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	Daclatasvir	Tablets, oral, 3 mg, Daily, 48 weeks
DRUG	Daclatasvir	Tablets, oral, 10 mg, Daily, 48 weeks
DRUG	Daclatasvir	Tablets, oral, 60 mg, Daily, 48 weeks
DRUG	Placebo	Tablet, oral, 0 mg, Daily 48 weeks
DRUG	Peginterferon alpha-2a	Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
DRUG	ribavirin	Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-11-01
• Completion: 2011-01-01
• First posted: 2009-04-03
• Last updated: 2015-10-23
• Results posted: 2015-10-23

Locations

14 sites across 2 countries: United States, France