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Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection

NCT01492426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 605

Last updated 2016-06-03

Study results available
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Summary

The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Conditions

  • Hepatitis C

Interventions

DRUG

Daclatasvir

Film-coated tablet, oral, 60 mg, once daily, 24 weeks

DRUG

Telaprevir

Film-coated tablet, oral, 750 mg, 3 times daily

DRUG

Peginterferon alfa-2a

Solution for injection, subcutaneous injection, 180 μg, weekly

DRUG

Ribavirin

Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Poland
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01492426 on ClinicalTrials.gov