NCT01170962

Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment

A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 512 (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-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	BMS-790052	Film coated tablet, Oral, 20 mg, once daily, 24 weeks
DRUG	BMS-790052	Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
DRUG	Placebo	Film coated tablet, Oral, 0mg, Once daily, 24 weeks
DRUG	peginterferon alfa-2a	Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
DRUG	ribavirin	Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2010-07-28
• Last updated: 2015-10-12
• Results posted: 2015-10-12

Locations

72 sites across 11 countries: United States, Argentina, Australia, Canada, Denmark, France, Germany, Italy, Mexico, Puerto Rico, Sweden