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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 - NCT01142700-32803(Clinical Trial 701426)



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City:  Orlando
State:  
FL
Zip Code: 32803
Conditions: Chronic Hepatitis C Virus Genotype 1
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - 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 Criteria: - 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
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Data Source: ClinicalTrials.gov
Date Processed: February 18, 2011
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