EUCTR2010-019585-90-ES进行中（未招募）1 期
A Randomized, Open-label, Multicenter Study to Evaluate the SustainedVirologic Response of the HCV Protease Inhibitor Danoprevir Boostedwith Low Dose Ritonavir (Danoprevir/r) and Copegus®, in Combinationwith the HCV Polymerase Inhibitor Prodrug RO5024048 and/orPegasys® in Chronic Hepatitis C Genotype 1 Patients Who Failed with aPrevious Course of Peginterferon alfa plus Ribavirin CombinationTherapy - Matterhorn
F.Hoffmann-La Roche0 个研究点目标入组 420 人开始时间: 2011年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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:
- •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
- •- Patients with cirrhosis
- •- Patients who were discontinued from previous peginterferon plus
- •ribavirin therapy due to reasons other than insufficient therapeutic
- •- Co-infection with hepatitis B or human immunodeficiency virus (HIV)
- •- History or evidence of chronic liver disease other than hepatitis C
研究者
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