Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C

In brief

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Key facts

Study ID

NCT01448044

Run by

Bristol-Myers Squibb

People needed

152

Starts

2011-12-01

Expected to finish

2014-01-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants chronically infected with HCV Genotype 4
• HCV RNA viral load of ≥ 10,000 IU/mL
• No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
• Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted

You may not qualify if…

• Evidence of decompensated liver disease
• Documented or suspected Hepatocellular carcinoma (HCC)
• Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening

Where it is running

• Scti Research Foundation — San Clemente, California, United States
• Umass Memorial Medical Center — Worcester, Massachusetts, United States
• University Gastroenterology — Providence, Rhode Island, United States
• Metropolitan Research — Annandale, Virginia, United States
• Local Institution — Bondy, France
• Local Institution — Créteil, France
• Local Institution — La Roche-sur-Yon, France
• Local Institution — Marseille, France
• Local Institution — Nice, France
• Local Institution — Orléans, France
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Strasbourg, France
• Local Institution — Toulouse, France
• Local Institution — Villejuif, France
• Local Institution — Thesaloniki, Greece
• Local Institution — Roma, Italy
• Local Institution — Torino, Italy
• Local Institution — San Juan, Puerto Rico
• Local Institution — A Coruña, Spain
• Local Institution — Barcelona, Spain
• Local Institution — Barcelona, Spain
• Local Institution — Madrid, Spain
• Local Institution — London, Greater London, United Kingdom
• Local Institution — London, Greater London, United Kingdom

Full record on ClinicalTrials.gov

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