NCT01257204

Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	Placebo	Tablets, oral, 0 mg, once daily, for 24 weeks
DRUG	Daclatasvir	Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
DRUG	Pegylated interferon alfa-2a	Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
DRUG	Ribavirin	Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-05-01
• Completion: 2012-09-01
• First posted: 2010-12-09
• Last updated: 2015-12-14
• Results posted: 2015-12-14

Locations

26 sites across 6 countries: United States, Australia, Canada, Denmark, France, Italy