Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
NCT ID: NCT01309932
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
165 participants
INTERVENTIONAL
2011-03-31
2014-09-30
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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A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin
Part A
Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin
Part A
Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
Tablets, Oral, 0 mg, Once daily, 24 weeks
A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV
Part A
Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Pegylated Interferon Alfa-2a (pegIFNα-2a)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks
Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
Tablets, Oral, 0 mg, Once daily, 24 weeks
A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)
Part B
BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks
A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)
Part B
Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks
BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks
BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks
A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)
Part B
BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)
Part B
Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks
BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks
Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 16 weeks
Interventions
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Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Pegylated Interferon Alfa-2a (pegIFNα-2a)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks
Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks
Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks
BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks
BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks
Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
Tablets, Oral, 0 mg, Once daily, 24 weeks
Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 16 weeks
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 Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
* Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%
Exclusion Criteria
* Co-infection with HIV;
* Diagnosed or suspected hepatocellular carcinoma;
* Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin
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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Mayo Clinic Hospital
Phoenix, Arizona, United States
Desert Medical Group Inc.
Palm Springs, California, United States
University Of Colorado Denver And Hospital
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Johns Hopkins University
Lutherville, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Bristol-Myers Squibb/David E. Bernstein, Md
Manhasset, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Local Institution
Adelaide, South Australia, Australia
Local Institution
Clayton Vic, Victoria, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Perth, Western Australia, Australia
Local Institution
Clichy, , France
Local Institution
Créteil, , France
Local Institution
Montpellier, , France
Local Institution
Nice, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Essen, , Germany
Local Institution
Frankfurt, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Pisa, , Italy
Local Institution
Roma, , Italy
Local Institution
Hiroshima, Hiroshima, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kawasaki-shi, Kanagawa, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Iruma-gun, Saitama, Japan
Local Institution
Minato-ku, Tokyo, Japan
Local Institution
Musashino-shi, Tokyo, Japan
Local Institution
Grafton, Auckland, New Zealand
Local Institution
Christchurch, , New Zealand
Fundacion De Investigacion De Diego
San Juan, , Puerto Rico
Local Institution
Barcelona, Barcelona, Spain
Local Institution
Valencia, , Spain
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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2010-022568-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI452-008
Identifier Type: -
Identifier Source: org_study_id
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