Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

Completed · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Key facts

Study ID

NCT01359644

Run by

Bristol-Myers Squibb

People needed

350

Starts

2011-06-01

Expected to finish

2013-10-01

Last updated by the study team

2015-10-23

Who can join

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

You may qualify if…

• Men and women, ages 18 to 70 years.
• Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
• Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

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 hemophilia.
• History of torsade de pointes.
• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
• History of gastrointestinal disease or surgical procedure (except cholecystectomy).
• History of clinically significant cardiac disease.
• Blood transfusion within 4 weeks prior to study drug administration.
• Poor venous access.
• Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

Where it is running

• Southern California Liver Centers — Coronado, California, United States
• Research And Education, Inc. — San Diego, California, United States
• University Of Colorado Denver & Hospital — Aurora, Colorado, United States
• University Of Florida Hepatology — Gainesville, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• University Of Michigan Health System — Ann Arbor, Michigan, United States
• Weill Cornell Medical College — New York, New York, United States
• Bronx Va Medical Center 3c Sub-J — The Bronx, New York, United States
• Options Health Research, Llc — Tulsa, Oklahoma, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Metropolitan Research — Annandale, Virginia, United States
• Dean Clinic — Madison, Wisconsin, United States
• Local Institution — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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