Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C Virus

In brief

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

Key facts

Study ID

NCT01030432

Run by

Bristol-Myers Squibb

People needed

285

Starts

2010-02-01

Expected to finish

2012-10-01

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…

• Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
• Subjects chronically infected with HCV genotype 4 (Phase 2b only)
• HCV RNA viral load of ≥ 10*5* IU/mL at screening
• BMI of 18 - 35 kg/m² at screening

You may not qualify if…

• Cirrhosis (Phase 2a only)
• Decompensated cirrhosis (Phase 2b)
• Co-infection with HBV or HIV
• Hepatocellular carcinoma
• Prior treatment with anti-HCV drugs

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• Alabama Liver & Digestive Specialists (Alds) — Montgomery, Alabama, United States
• Florida Hospital Transplant Center — Orlando, Florida, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• The Research Institute — Springfield, Massachusetts, United States
• Umass Memorial Medical Center — Worcester, Massachusetts, United States
• James J Peters Vamc — The Bronx, New York, United States
• University Of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• Oregon Health Science Univ — Portland, Oregon, United States
• Hospital Of The University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Gastro One — Germantown, Tennessee, United States
• Metropolitan Research — Fairfax, Virginia, United States
• Dean Clinic — Madison, Wisconsin, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — Prov. Buenos Aires, Buenos Aires, Argentina
• Local Institution — Prov de Santa Fe, Santa Fe Province, Argentina
• Local Institution — Créteil, France
• Local Institution — Marseille, France
• Local Instituition — Montpellier, France
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Vandœuvre-lès-Nancy, France
• Local Institution — Frankfurt, Germany

Full record on ClinicalTrials.gov

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