跳至主要内容
临床试验/EUCTR2010-019585-90-AT
EUCTR2010-019585-90-AT进行中(未招募)不适用

A Randomized, Open-label, Multicenter Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir Boosted with Low Dose Ritonavir (Danoprevir/r) and Copegus®, in Combination with the HCV Polymerase Inhibitor Prodrug RO5024048 and/or Pegasys® in Chronic Hepatitis C Genotype 1 Patients Who Failed with a Previous Course of Peginterferon alfa plus Ribavirin Combination Therapy - Matterhorn

F.Hoffmann-La Roche0 个研究点目标入组 420 人开始时间: 2011年2月24日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
420

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Adult patients, age 18 years and older
  • - Presence of hepatitis C infection, genotype 1a or 1b
  • - Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
  • - Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 395
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 25

排除标准

  • - Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
  • - Patients with cirrhosis
  • - Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
  • - Co-infection with hepatitis B or human immunodeficiency virus (HIV)
  • - History or evidence of chronic liver disease other than hepatitis C

研究者

发起方
F.Hoffmann-La Roche

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