Status:
COMPLETED
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed Description
Allocation: Randomized Stratified
Eligibility Criteria
Inclusion
- Key
- Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
- HCV RNA viral load ≥10,000 IU/mL
- No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
- No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
- Body mass index of 18 to 35 kg/m\^2
- Negative for HIV and hepatitis B virus
- Key
Exclusion
- Evidence of decompensated liver disease
- Evidence of medical condition other than HCV contributing to chronic liver disease
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT01492426
Start Date
January 1 2012
End Date
March 1 2014
Last Update
June 3 2016
Active Locations (91)
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1
The Kirklin Clinic
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
3
Va Long Beach Healthcare System
Long Beach, California, United States, 90822
4
Medical Associates Research Group
San Diego, California, United States, 92123