A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C Virus Genotype 1

In brief

Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.

Key facts

Study ID

NCT01142700

Run by

Bristol-Myers Squibb

People needed

0

Starts

2010-07-01

Expected to finish

2010-12-01

Last updated by the study team

2011-03-15

Who can join

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

You may qualify if…

• Treatment-naive subjects with genotype 1 chronic HCV
• HCV RNA ≥ 100,000 IU/mL at screening
• Seronegative for HIV and HBsAg
• Liver biopsy within prior 2 years demonstrating no cirrhosis

You may not qualify if…

• Any evidence of liver disease other than hepatitis C
• Diagnosed or suspected hepatocellular carcinoma
• Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
• Cirrhosis

Where it is running

• Local Institution — Coronado, California, United States
• Research And Education, Inc. — San Diego, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Bach And Godofsky Infectious Diseases — Bradenton, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Vita Medical Center & Research Solutions, Inc. — Tamarac, Florida, United States
• Gastrointestinal Specialists Of Georgia Pc — Mareitta, Georgia, United States
• Maryland Digestive Disease Research — Laurel, Maryland, United States
• Local Institution — Philadelphia, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Liver Institute Of Virginia Bon Secours Health System — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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