NCT01012895

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (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 determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	BMS-790052	Tablets, Oral, 60 mg, once daily, 24 weeks
DRUG	BMS-650032	Tablets, Oral, 600 mg, twice daily, 24 weeks
DRUG	BMS-650032	Tablets, Oral, 200mg, twice daily, 24 weeks
DRUG	BMS-650032	Tablets, Oral, 200 mg, once daily, 24 weeks
DRUG	Pegylated-interferon alfa-2a	Syringe, Subcutaneous Injection, 180 µg, once weekly
DRUG	Ribavirin	Tablets, Oral For subjects weighing \< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg Twice daily (\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-10-01
• Completion: 2014-02-01
• First posted: 2009-11-13
• Last updated: 2015-10-09

Locations

18 sites across 3 countries: United States, France, Puerto Rico