Status:
COMPLETED
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Subjects chronically infected with HCV genotype 1
- Non-responder to prior therapy with peginterferon alfa and ribavirin
- HCV RNA viral load of 100,00 IU/mL
- Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
- Body Mass Index (BMI) of 18 to 35 kg/m2
Exclusion
- Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
512 Patients enrolled
Trial Details
Trial ID
NCT01170962
Start Date
August 1 2010
End Date
December 1 2012
Last Update
October 12 2015
Active Locations (72)
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1
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States, 36116
2
Scripps Clinic
La Jolla, California, United States, 92037
3
CLI
Los Angeles, California, United States, 90048
4
Desta Digestive Disease Medical Center
San Diego, California, United States, 92114