A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 512
- 试验地点
- 37
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
研究概览
简要总结
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.
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
- Triple (Participant, Care Provider, Investigator)
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
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
干预措施: BMS-790052 (Drug)
Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
干预措施: peginterferon alfa-2a (Drug)
Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
干预措施: ribavirin (Drug)
Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
干预措施: BMS-790052 (Drug)
Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
干预措施: peginterferon alfa-2a (Drug)
Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
干预措施: ribavirin (Drug)
Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
干预措施: BMS-790052 (Drug)
Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
干预措施: peginterferon alfa-2a (Drug)
Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
干预措施: ribavirin (Drug)
Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
干预措施: BMS-790052 (Drug)
Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
干预措施: peginterferon alfa-2a (Drug)
Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
干预措施: ribavirin (Drug)
Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
(prior partial responders only)
干预措施: Placebo (Drug)
Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
(prior partial responders only)
干预措施: peginterferon alfa-2a (Drug)
Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
(prior partial responders only)
干预措施: ribavirin (Drug)
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)(Follow-up Week 12)
- 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)
- Percentage of Participants With Complete Early Virologic Response (cEVR)(Week 12)
- Percentage of Participants With Rapid Virologic Response (RVR)(Week 4)
- 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)