Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
NCT ID: NCT01170962
Last Updated: 2015-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
512 participants
INTERVENTIONAL
2010-08-31
2012-12-31
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
TRIPLE
Study Groups
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Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
(prior partial responders only)
Placebo
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Interventions
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BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Placebo
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-responder to prior therapy with peginterferon alfa and ribavirin
* HCV RNA viral load of 100,00 IU/mL
* Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
* Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
* Body Mass Index (BMI) of 18 to 35 kg/m2
Exclusion Criteria
* Evidence of medical condition associated with chronic liver disease other than HCV
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
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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Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States
Scripps Clinic
La Jolla, California, United States
CLI
Los Angeles, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
University Of California At San Francisco
San Francisco, California, United States
California Pacific Medical Center
San Francisco, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
Transplant Center And Hepatology Clinic, B-154
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
University Of Florida Hepatology
Gainesville, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States
Johns Hopkins Medical Institutions
Lutherville, Maryland, United States
The Research Institute
Springfield, Massachusetts, United States
Saint Louis University
St Louis, Missouri, United States
Samuel S. Stratton Vamc
Albany, New York, United States
James Sungsik Park, M.D. C.N.S.C.
Great Neck, New York, United States
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, United States
University Of Rochester Medical Center
Rochester, New York, United States
James J Peters Vamc
The Bronx, New York, United States
University Of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
North Texas Research Institute
Arlington, Texas, United States
Liver Associates Of Texas
Houston, Texas, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution
Prov de Santa Fe, Santa Fe Province, Argentina
Local Institution
Randwick, New South Wales, Australia
Local Institution
Clayton, Victoria, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Prahan, Victoria, Australia
Local Institution
Fremantle, Western Australia, Australia
Local Institution
Perth, Western Australia, Australia
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Aarhus, , Denmark
Local Institution
Hvidovre, , Denmark
Local Institution
Odense, , Denmark
Local Institution
Clichy, , France
Local Institution
Créteil, , France
Local Institution
Lyon, , France
Local Institution
Nice, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Essen, , Germany
Local Institution
Frankfurt, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Hanover, , Germany
Local Institution
Cisanello (pisa), , Italy
Local Institution
Pavia, , Italy
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Cuernavaca, Morelos, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Instituto De Investigacion Cientifica Del Sur
Ponce, , Puerto Rico
Local Institution
San Juan, , Puerto Rico
Local Institution
Gothenburg, , Sweden
Local Institution
Stockholm, , Sweden
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2010-019378-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-011
Identifier Type: -
Identifier Source: org_study_id
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