Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 11
- 主要终点
- Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Arm 1: Sentinel A
BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
干预措施: BMS-790052 (Drug)
Arm 1: Sentinel A
BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
干预措施: BMS-650032 (Drug)
Arm 2: Sentinel B
BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: BMS-790052 (Drug)
Arm 2: Sentinel B
BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: BMS-650032 (Drug)
Arm 2: Sentinel B
BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: Pegylated-interferon alfa-2a (Drug)
Arm 2: Sentinel B
BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: Ribavirin (Drug)
Arm 5: Expansion B1
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: Pegylated-interferon alfa-2a (Drug)
Arm 3: Expansion A1
BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
干预措施: BMS-790052 (Drug)
Arm 3: Expansion A1
BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
干预措施: BMS-650032 (Drug)
Arm 4: Expansion A2
BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
干预措施: BMS-790052 (Drug)
Arm 4: Expansion A2
BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
干预措施: BMS-650032 (Drug)
Arm 5: Expansion B1
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: BMS-790052 (Drug)
Arm 5: Expansion B1
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: BMS-650032 (Drug)
Arm 5: Expansion B1
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: Ribavirin (Drug)
Arm 6: Expansion B2
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: BMS-790052 (Drug)
Arm 6: Expansion B2
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: BMS-650032 (Drug)
Arm 6: Expansion B2
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: Pegylated-interferon alfa-2a (Drug)
Arm 6: Expansion B2
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
干预措施: Ribavirin (Drug)
Arm 7: Expansion B3
BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
干预措施: BMS-790052 (Drug)
Arm 7: Expansion B3
BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
干预措施: BMS-650032 (Drug)
Arm 7: Expansion B3
BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
干预措施: Ribavirin (Drug)
结局指标
主要结局
Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment
时间窗: 12 weeks post treatment
次要结局
- 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)
- 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)