Status:
WITHDRAWN
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C Virus Genotype 1
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01142700
Start Date
July 1 2010
End Date
December 1 2010
Last Update
March 15 2011
Active Locations (11)
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1
Local Institution
Coronado, California, United States, 92118
2
Research And Education, Inc.
San Diego, California, United States, 92105
3
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Bach And Godofsky Infectious Diseases
Bradenton, Florida, United States, 34209