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

NCT01170962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2015-10-12

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-06-30
Completion
2012-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Mexico
  • Puerto Rico
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01170962 on ClinicalTrials.gov