NCT01466192已完成3 期
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 2 Hepatitis C, Who Relapsed After Previous Treatment
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
- 108
- 试验地点
- 1
- 主要终点
- Undetectable HCV 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 and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 2, chronic hepatitis C
- •Relapsers (patient who relapsed after previous 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 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
MP-424
Experimental
干预措施: Ribavirin (Drug)
MP-424
Experimental
干预措施: Peginterferon alfa-2b (Drug)
结局指标
主要结局
Undetectable HCV 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)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected PatientsChronic Hepatitis CNCT01468584Tanabe Pharma Corporation10
已完成
3 期
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based TherapyHepatitis CNCT00781274Tanabe Pharma Corporation32
已完成
3 期
Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based TherapyChronic Hepatitis CNCT00780910Tanabe Pharma Corporation109
已完成
3 期
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis CHepatitis CNCT00780416Tanabe Pharma Corporation189
已完成
3 期
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis CChronic Hepatitis C (CHC)NCT01753557Tanabe Pharma Corporation54