Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Completed · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

Key facts

Study ID

NCT01012895

Run by

Bristol-Myers Squibb

People needed

215

Starts

2009-12-01

Expected to finish

2014-02-01

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…

• Male and female subjects ages 18 to 70 years
• HCV-Infected Genotype 1 Null responders to current standard of care
• Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.

You may not qualify if…

• Evidence of a medical condition associate with chronic liver disease other than HCV
• History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
• History of Cancer within 5 years of enrollment
• History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
• History of clinically significant cardiac disease
• History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Documented cirrhosis within 12 months prior to dosing
• Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
• Pregnant

Where it is running

• Advanced Clinical Research Institute — Anaheim, California, United States
• Southern California Liver Centers — Coronado, California, United States
• San Jose Gastroenterology — San Jose, California, United States
• University Of Colorado Denver & Hospital — Aurora, Colorado, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• University Of Michigan Health System — Ann Arbor, Michigan, United States
• Carolinas Center For Liver Disease — Statesville, North Carolina, United States
• Texas Clinical Research Institute, Llc — Arlington, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Metropolitan Research — Fairfax, Virginia, United States
• Local Institution — Clichy, France
• Local Institution — Créteil, France
• Local Institution — Marseille, France
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Pessac, France
• Local Institution — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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