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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C Virus

In brief

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.

Key facts

Study ID

NCT01170962

Run by

Bristol-Myers Squibb

People needed

512

Starts

2010-08-01

Expected to finish

2012-12-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Clinic — La Jolla, California, United States
• CLI — Los Angeles, California, United States
• Desta Digestive Disease Medical Center — San Diego, California, United States
• University Of California At San Francisco — San Francisco, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Kaiser Permanente Medical Center — San Francisco, California, United States
• Transplant Center And Hepatology Clinic, B-154 — Aurora, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• University Of Florida Hepatology — Gainesville, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Digestive Disease Associates, P.A. — Baltimore, Maryland, United States
• Johns Hopkins Medical Institutions — Lutherville, Maryland, United States
• The Research Institute — Springfield, Massachusetts, United States
• Saint Louis University — St Louis, Missouri, United States
• Samuel S. Stratton Vamc — Albany, New York, United States
• James Sungsik Park, M.D. C.N.S.C. — Great Neck, New York, United States
• Upper Delaware Valley Infectious Diseases, Pc — Monticello, New York, United States
• University Of Rochester Medical Center — Rochester, New York, United States
• James J Peters Vamc — The Bronx, New York, United States
• University Of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
• Carolinas Center For Liver Disease — Statesville, North Carolina, United States
• Alabama Liver & Digestive Specialists (Alds) — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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