165
Participants
Start Date
March 31, 2011
Primary Completion Date
July 31, 2014
Study Completion Date
September 30, 2014
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
Local Institution, Grafton
Local Institution, Heidelberg
Local Institution, Clayton Vic
Local Institution, Adelaide
Local Institution, Perth
Local Institution, Christchurch
Bristol-Myers Squibb/David E. Bernstein, Md, Manhasset
Local Institution, Hamburg
Johns Hopkins University, Lutherville
Metropolitan Research, Fairfax
Carolinas Medical Center, Charlotte
Carolinas Center For Liver Disease, Statesville
Local Institution, Montpellier
Local Institution, Essen
Local Institution, Valencia
Henry Ford Health System, Detroit
Local Institution, Pisa
Local Institution, Frankfurt
Local Institution, Paris
Local Institution, Paris
St. Luke'S Episcopal Hospital - Baylor College Of Medicine, Houston
Texas Liver Institute, San Antonio
University Of Colorado Denver And Hospital, Aurora
Mayo Clinic Hospital, Phoenix
Local Institution, Clichy
Desert Medical Group Inc., Palm Springs
Local Institution, Créteil
Virginia Mason Medical Center, Seattle
Local Institution, Kawasaki-shi
Local Institution, Iruma-gun
Local Institution, Osaka
Local Institution, Hiroshima
Yale University School Of Medicine, New Haven
Local Institution, Nice
Local Institution, Roma
Local Institution, Sapporo
Local Institution, Minato-ku
Local Institution, Musashino-shi
Fundacion De Investigacion De Diego, San Juan
Local Institution, Barcelona
Lead Sponsor
Bristol-Myers Squibb
INDUSTRY