Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
Phase 2
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01012895
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 215
Inclusion Criteria
- Male and female subjects ages 18 to 70 years
- HCV-Infected Genotype 1 Null responders to current standard of care
- Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.
Exclusion Criteria
- Evidence of a medical condition associate with chronic liver disease other than HCV
- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
- History of Cancer within 5 years of enrollment
- History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
- History of clinically significant cardiac disease
- History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Documented cirrhosis within 12 months prior to dosing
- Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
- Pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Sentinel A BMS-790052 BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily Arm 1: Sentinel A BMS-650032 BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily Arm 2: Sentinel B BMS-790052 BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin Arm 2: Sentinel B BMS-650032 BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin Arm 3: Expansion A1 BMS-650032 BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily Arm 4: Expansion A2 BMS-650032 BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily Arm 5: Expansion B1 BMS-790052 BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin Arm 2: Sentinel B Pegylated-interferon alfa-2a BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin Arm 5: Expansion B1 Pegylated-interferon alfa-2a BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin Arm 6: Expansion B2 BMS-650032 BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin Arm 6: Expansion B2 Pegylated-interferon alfa-2a BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin Arm 7: Expansion B3 BMS-650032 BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin Arm 5: Expansion B1 BMS-650032 BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin Arm 2: Sentinel B Ribavirin BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin Arm 3: Expansion A1 BMS-790052 BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily Arm 4: Expansion A2 BMS-790052 BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily Arm 5: Expansion B1 Ribavirin BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin Arm 6: Expansion B2 BMS-790052 BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin Arm 6: Expansion B2 Ribavirin BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin Arm 7: Expansion B3 BMS-790052 BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin Arm 7: Expansion B3 Ribavirin BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
- Primary Outcome Measures
Name Time Method Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment 12 weeks post treatment
- Secondary Outcome Measures
Name Time Method Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results 12 weeks post-treatment Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)
Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16 Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. Day 1 and Day 14 Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. Day 1 and Day 14 Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. Day 1 and Day 14
Trial Locations
- Locations (11)
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Carolinas Center For Liver Disease
🇺🇸Statesville, North Carolina, United States
Texas Clinical Research Institute, Llc
🇺🇸Arlington, Texas, United States
University Of Colorado Denver & Hospital
🇺🇸Aurora, Colorado, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Local Institution
🇵🇷San Juan, Puerto Rico
Southern California Liver Centers
🇺🇸Coronado, California, United States
San Jose Gastroenterology
🇺🇸San Jose, California, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
University Of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States