NCT01447394撤回3 期
A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response
研究概览
简要总结
The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Chronic hepatitis C, Genotype 1 or 4
- •HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
- •Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
- •Naive to prior anti-HCV therapy
排除标准
- •Infected with HCV other than Genotype 1 or 4
- •Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
- •Evidence of liver disease other than HCV
- •Active substance abuse
- •Use of hematologic growth factors within 90 days prior to study randomization
- •Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
研究组 & 干预措施
Arm 1: Pegylated Interferon Lambda + Ribavirin
Experimental
干预措施: Pegylated Interferon Lambda (Biological)
Arm 1: Pegylated Interferon Lambda + Ribavirin
Experimental
干预措施: Ribavirin (Drug)
Arm 2: Pegylated Interferon Alfa-2a + Ribavirin
Active Comparator
干预措施: Pegylated Interferon Alfa-2a (Biological)
Arm 2: Pegylated Interferon Alfa-2a + Ribavirin
Active Comparator
干预措施: Ribavirin (Drug)
结局指标
主要结局
Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response
时间窗: At follow-up Week 24 (SVR24) following 48 weeks of treatment
The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities
时间窗: From Day 1 to end of Week 48 on-treatment
次要结局
- Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms(From Day 1 to end of Week 48 on-treatment)
研究者
研究点 (1)
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