Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
NCT ID: NCT01030432
Last Updated: 2015-10-09
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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COMPLETED
PHASE2
285 participants
INTERVENTIONAL
2010-02-28
2012-10-31
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
QUADRUPLE
Study Groups
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Phase 2a: Arm 1
BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Phase 2a: Arm 2
Placebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Phase 2b: Arm 1
Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
Placebo
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Phase 2b: Arm 2
Placebo
Tablets, Oral, 0 mg, twice daily 24 weeks
Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Interventions
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Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
Placebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
Placebo
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Placebo
Tablets, Oral, 0 mg, twice daily 24 weeks
Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects chronically infected with HCV genotype 4 (Phase 2b only)
* HCV RNA viral load of ≥ 10\*5\* IU/mL at screening
* BMI of 18 - 35 kg/m² at screening
Exclusion Criteria
* Decompensated cirrhosis (Phase 2b)
* Co-infection with HBV or HIV
* Hepatocellular carcinoma
* Prior treatment with anti-HCV drugs
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States
Florida Hospital Transplant Center
Orlando, Florida, United States
Mercy Medical Center
Baltimore, Maryland, United States
The Research Institute
Springfield, Massachusetts, United States
Umass Memorial Medical Center
Worcester, Massachusetts, United States
James J Peters Vamc
The Bronx, New York, United States
University Of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Oregon Health Science Univ
Portland, Oregon, United States
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Gastro One
Germantown, Tennessee, United States
Metropolitan Research
Fairfax, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution
Prov. Buenos Aires, Buenos Aires, Argentina
Local Institution
Prov de Santa Fe, Santa Fe Province, Argentina
Local Institution
Créteil, , France
Local Institution
Marseille, , France
Local Instituition
Montpellier, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Frankfurt, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Mainz, , Germany
Local Institution
Würzburg, , Germany
Local Institution
Dublin, Dublin, Ireland
Local Institution
Torino, , Italy
Local Institution
Alicante, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Málaga, , Spain
Local Institution
Valencia, , Spain
Local Institution
London, Greater London, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom
Local Institution
Glasgow, Lanarkshire, United Kingdom
Countries
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References
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Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2009-013652-69
Identifier Type: REGISTRY
Identifier Source: secondary_id
AI447-016
Identifier Type: -
Identifier Source: org_study_id
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