The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin
IND numbers: 79,599; 101,943
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12)
Time frame: 12 weeks post-treatment
Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Proportion of subjects with HCV ribonucleic acid (RNA) undetectable
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Proportion of subjects who experience viral breakthrough
viral breakthrough defined as: * Any increase in HCV RNA ≥ 1 log10 from nadir or * Any quantifiable HCV RNA ≥ 25 IU/mL (\> LOQ) on or after Week 8
Time frame: Formal analysis at SVR12, Week 48 of follow up period (or upon occurrence)
Proportion of subjects who experience viral relapse defined as confirmed quantifiable HCV RNA ≥ 25 IU/mL (>LOQ) in a subject with HCV RNA < LOQ or undetectable at End of treatment (EOT)
Time frame: End of treatment (Maximum up to 24 Weeks)
Maximum observed plasma concentration (Cmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time frame: Day 1 and Day 14
Observed plasma concentration at 12 hours (C12) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time frame: Day 1 and Day 14
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The Kirklin Clinic
Birmingham, Alabama, United States
Southern California Research Center
Coronado, California, United States
Peter J Ruane Md Inc
Los Angeles, California, United States
Va Greater Los Angeles Healthcare System
Los Angeles, California, United States
Research And Education, Inc.
San Diego, California, United States
Precision Research Institute, Llc
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
University Of Colorado Denver And Hospital
Aurora, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Orlando Immunology Center
Orlando, Florida, United States
...and 22 more locations
Observed plasma concentration at 24 hours (C24) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time frame: Day 1 and Day 14
Trough observed plasma concentration (Ctrough) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time frame: Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time frame: Day 1 and Day 14
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time frame: Day 1 and Day 14
HCV genomic substitutions associated with exposure of BMS-650032, BMS-790052, and BMS-791325
Time frame: At the time of viral breakthrough or relapse
Frequency of deaths, serious adverse events (SAEs), discontinuations due to adverse events (AEs), severity Grade 3/4 AEs, and severity Grade 3/4 laboratory abnormalities
Time frame: Formal analysis at week 48 of follow up period (or upon occurrence)