NCT00780416已完成3 期
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
研究概览
简要总结
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Genotype 1, chronic hepatitis C
- •Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
- •Able and willing to follow contraception requirements
排除标准
- •Cirrhosis of the liver or hepatic failure
- •Hepatitis B surface antigen-positive or HIV antibodies-positive
- •History of, or concurrent hepatocellular carcinoma
- •History of, or concurrent depression, schizophrenia; or suicide attempt in the past
- •Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
研究组 & 干预措施
TRV/PEG/RBV
Experimental
干预措施: MP-424 (Drug)
TRV/PEG/RBV
Experimental
干预措施: Ribavirin (Drug)
TRV/PEG/RBV
Experimental
干预措施: Peginterferon Alfa-2b (Drug)
PEG/RBV
Active Comparator
干预措施: Ribavirin (Drug)
PEG/RBV
Active Comparator
干预措施: Peginterferon Alfa-2b (Drug)
结局指标
主要结局
The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
时间窗: After 24 weeks of follow-up
次要结局
未报告次要终点
研究者
研究点 (1)
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