EUCTR2011-004653-31-GB进行中（未招募）不适用
A multicenter, single-arm trial evaluating the safety and efficacy of DEB025/Alisporivir in combination with pegylated interferon-a2a and ribavirin (peg-IFNa2a/RBV) in protease inhibitor treatment failure patients with chronic hepatitis C genotype 1
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 173
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
- •1.HCV GT1 patients with previous PI treatment failure.
- •2.Timing of the PI treatment. the minimum time from the last dose of previous PI treatment to the first dose of study medication is three months.
- •3.Diagnosed Chronic hepatitis C virus infection
- •4.Infection with HCV genotype 1
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Use of other investigational drugs at the time of enrollment,
- •2.History of hypersensitivity to any pegIFN or RBV.
- •3.Any null non-responders to prior pegIFN/RBV treatment,
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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Alisporivir con pegIFN / RBV in pazienti con epatite C cronica con precedente fallimento terapeutico all'inibitore della proteasiEUCTR2011-004653-31-ITOVARTIS FARMA173
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Alisporivir with pegIFN/RBV in protease inhibitor (PI) treatment failure patients with chronic hepatitis CEUCTR2011-004653-31-DEovartis Pharma Services AG173
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Alisporivir with pegIFN/RBV in protease inhibitor (PI) treatment failure patients with chronic hepatitis CChronic hepatitis C genotype 1 protease inhibitor (PI) treatment failureMedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-004653-31-ESovartis Farmacéutica S.A173
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