NCT01753570已完成3 期
A Phase 3 Study of MP-424 in Combination With IFN Beta and RBV, in Subjects With Genotype 1/2 Hepatitis C, Who Are Treatment-Naïve or Have Received Interferon Based Therapy
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
- 74
- 试验地点
- 1
- 主要终点
- Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) 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 IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
- •Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based treatment
- •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 serious 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
RBV+IFN beta, Genotype1
Experimental
干预措施: RBV(48 weeks) (Drug)
RBV+IFN beta, Genotype1
Experimental
干预措施: IFN beta(48 weeks) (Drug)
MP-424+RBV+IFN beta, Genotype2
Experimental
干预措施: MP-424 (Drug)
MP-424+RBV+IFN beta, Genotype2
Experimental
干预措施: RBV(24 weeks) (Drug)
MP-424+RBV+IFN beta, Genotype2
Experimental
干预措施: IFN beta(24 weeks) (Drug)
MP-424+RBV+IFN beta, Genotype1
Experimental
干预措施: MP-424 (Drug)
MP-424+RBV+IFN beta, Genotype1
Experimental
干预措施: RBV(24 weeks) (Drug)
MP-424+RBV+IFN beta, Genotype1
Experimental
干预措施: IFN beta(24 weeks) (Drug)
结局指标
主要结局
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
时间窗: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)
次要结局
- Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)(4 weeks)
- Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.(From baseline to 24 weeks after completion of drug administration)
- Transition of Serum HCV RNA Levels(Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks)
- Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration(60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta))
- Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)(48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta))
研究者
研究点 (1)
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