NCT01030432

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 285 (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 one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	BMS-650032	Tablets, Oral, 200 mg, Twice Daily, 48 weeks
DRUG	BMS-650032	Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
DRUG	Placebo	Tablets, Oral, 0 mg, twice daily, 48 weeks
DRUG	Placebo	Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
DRUG	Placebo	Tablets, Oral, 0 mg, twice daily 24 weeks
DRUG	Peginterferon Alfa-2a	Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
DRUG	Peginterferon Alfa-2a	Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
DRUG	Ribavirin	Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
DRUG	Ribavirin	Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-12-11
• Last updated: 2015-10-09

Locations

40 sites across 8 countries: United States, Argentina, France, Germany, Ireland, Italy, Spain, United Kingdom