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
NCT ID: NCT01142700
Last Updated: 2011-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2010-07-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BMS-824393 (10mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
BMS-824393
Capsule, Oral, 10 mg, once daily
Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
BMS-824393 (30 mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
BMS-824393
Capsule, Oral, 30 mg, once daily
Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
BMS-824393 (100 mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
BMS-824393
Capsule, Oral, 100 mg, once daily
Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Placebo
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
Placebo
Capsule, Oral, 0 mg, once daily
Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Peginterferon alfa-2a plus Ribavirin
Weeks 13 - 48
Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Interventions
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BMS-824393
Capsule, Oral, 10 mg, once daily
BMS-824393
Capsule, Oral, 30 mg, once daily
BMS-824393
Capsule, Oral, 100 mg, once daily
Placebo
Capsule, Oral, 0 mg, once daily
Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥ 100,000 IU/mL at screening
* Seronegative for HIV and HBsAg
* Liver biopsy within prior 2 years demonstrating no cirrhosis
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2010-018702-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI451-004
Identifier Type: -
Identifier Source: org_study_id
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