The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients
Allocation: Randomized Stratified
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
605
Film-coated tablet, oral, 60 mg, once daily, 24 weeks
Film-coated tablet, oral, 750 mg, 3 times daily
Solution for injection, subcutaneous injection, 180 μg, weekly
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
Time frame: Week 12 (Follow-up period)
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.
Time frame: Week 4
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.
Time frame: Week 4, Week 12
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.
Time frame: Week 12
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.
Time frame: Week 24 (Follow-up period)
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.
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Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
The Kirklin Clinic
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Va Long Beach Healthcare System
Long Beach, California, United States
Medical Associates Research Group
San Diego, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Orlando Immunology Center
Orlando, Florida, United States
Atlanta Medical Center
Atlanta, Georgia, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
...and 81 more locations
Time frame: Week 12 (Follow-up period)