NCT01193361

Ph IIA Study (SOC +/- NS5B)

A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	BMS-791325	Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
DRUG	BMS-791325	Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
DRUG	Placebo	Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
DRUG	Peg-interferon alfa-2a	Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
DRUG	Ribavirin	Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-06-01
• Completion: 2012-11-01
• First posted: 2010-09-01
• Last updated: 2015-10-09

Locations

10 sites across 1 country: United States