Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
- Conditions
- Hepatitis C Virus
- Interventions
- Registration Number
- NCT01170962
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 512
- Subjects chronically infected with HCV genotype 1
- Non-responder to prior therapy with peginterferon alfa and ribavirin
- HCV RNA viral load of 100,00 IU/mL
- Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
- Body Mass Index (BMI) of 18 to 35 kg/m2
- Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin peginterferon alfa-2a (prior null responders) Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin BMS-790052 (prior null responders) Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin peginterferon alfa-2a (prior partial responders) Arm 5: Placebo plus peginterferon alfa-2a and ribavirin Placebo (prior partial responders only) Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin ribavirin (prior null responders) Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin BMS-790052 (prior null responders) Arm 5: Placebo plus peginterferon alfa-2a and ribavirin peginterferon alfa-2a (prior partial responders only) Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin peginterferon alfa-2a (prior null responders) Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin ribavirin (prior partial responders) Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin ribavirin (prior null responders) Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin peginterferon alfa-2a (prior partial responders) Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin BMS-790052 (prior partial responders) Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin BMS-790052 (prior partial responders) Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin ribavirin (prior partial responders) Arm 5: Placebo plus peginterferon alfa-2a and ribavirin ribavirin (prior partial responders only)
- Primary Outcome Measures
Name Time Method Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period From day 8 post last dose of treatment up-to Week 72 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.
Percentage of Participants With Extended Rapid Virologic Response (eRVR) Week 4, Week 12 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.
Percentage of Participants With 24-week Sustained Virologic Response (SVR24) Follow-up Week 24 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.
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment From first dose to last dose plus 7 days, up to 49 weeks 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) Follow-up Week 12 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.
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures Baseline to follow-up Week 48 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.
Percentage of Participants With Complete Early Virologic Response (cEVR) Week 12 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.
Percentage of Participants With Rapid Virologic Response (RVR) Week 4 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.
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures Baseline to follow-up Week 48 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.
Trial Locations
- Locations (37)
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
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