Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

Key facts

Study ID

NCT01309932

Run by

Bristol-Myers Squibb

People needed

165

Starts

2011-03-01

Expected to finish

2014-09-01

Last updated by the study team

2015-10-09

Who can join

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

You may qualify if…

• Chronic Hepatitis C, Genotype 1
• HCV RNA >100,000 IU/mL at screening;
• Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
• Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

You may not qualify if…

• Any evidence of liver disease other than HCV;
• Co-infection with HIV;
• Diagnosed or suspected hepatocellular carcinoma;
• Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Desert Medical Group Inc. — Palm Springs, California, United States
• University Of Colorado Denver And Hospital — Aurora, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Bristol-Myers Squibb/David E. Bernstein, Md — Manhasset, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Carolinas Center For Liver Disease — Statesville, North Carolina, United States
• St. Luke'S Episcopal Hospital - Baylor College Of Medicine — Houston, Texas, United States
• Texas Liver Institute — San Antonio, Texas, United States
• Metropolitan Research — Fairfax, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Local Institution — Adelaide, South Australia, Australia
• Local Institution — Clayton Vic, Victoria, Australia
• Local Institution — Heidelberg, Victoria, Australia
• Local Institution — Perth, Western Australia, Australia
• Local Institution — Clichy, France
• Local Institution — Créteil, France
• Local Institution — Montpellier, France
• Local Institution — Nice, France
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Essen, Germany
• Local Institution — Frankfurt, Germany

Full record on ClinicalTrials.gov

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