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临床试验/NCT02629172
NCT02629172已完成不适用

Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1

AbbVie388 个研究点 分布在 1 个国家目标入组 3,043 人开始时间: 2016年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,043
试验地点
388
主要终点
Percentage of Participants with Sustained Virologic Response (SVR12)

研究概览

简要总结

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 120 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HCV genotype 1 patients treated with paritaprevir/ritonavir/ombitasvir in daily practice

排除标准

  • Patients who have been previously treated with paritaprevir/ritonavir/ombitasvir

结局指标

主要结局

Percentage of Participants with Sustained Virologic Response (SVR12)

时间窗: 12 weeks after the last dose of study drug

Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug.

次要结局

  • Percentage of Participants with Virologic Failure After Treatment(Post-treatment 24 weeks)
  • Percentage of Participants with Sustained Virologic Response (SVR24)(24 weeks after the last dose of study drug)
  • Percentage of Participants with Virologic Failure During Treatment(Up to Week 12)

研究者

发起方
AbbVie
申办方类型
Industry
责任方
Sponsor

研究点 (388)

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