The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
512
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: Week 4, Week 12
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
SVR24 was defined as undetectable RNA (Hepatitis C Virus \[HCV\] RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: Follow-up Week 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time frame: From first dose to last dose plus 7 days, up to 49 weeks
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time frame: From day 8 post last dose of treatment up-to Week 72
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Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
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
...and 62 more locations
Percentage of Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \<lower limit of quantitation \[LLOQ\], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \<lower limit of quantitation \[LLOQ\], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: Week 12
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \<lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: Follow-up Week 12
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
Time frame: Baseline to follow-up Week 48
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.
Time frame: Baseline to follow-up Week 48