EUCTR2009-016560-36-DE进行中（未招募）1 期
A long-term monitoring study to evaluate the persistence of direct acting antiviral (DAA) treatment-resistant mutations or the durability of sustained virological response (SVR) in patients treated with DAA-containing regimens for chronic hepatitis C infection (CHC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 650
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. Patients who have participated in Roche DAA treatment protocol(s) for the treatment of CHC infection and have: • Developed DAA-associated resistance mutation(s) which persisted through to the last evaluation of drug resistance in the donor protocols, or achieved only a partial viral response or experienced viral breakthrough while on mericitabine treatment (see definitions in Appendix 1) not associated with selection of S282T resistance mutations or any newly identified mericitabine resistance mutation(s), or • Achieved SVR-24, as defined by each donor study protocol, measured by the Roche COBAS TaqMan HCV Test = 20 weeks after the last dose of study medication 2. Willingness to give written informed consent and willingness to participate in and comply with the study requirements
- •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 640
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients with any of the following will not be eligible for participation:
- •1. Patients participating in DAA resistance monitoring: initiation of treatment for
- •CHC after participation in the donor protocol (except prescribed PEG-IFN/RBV
- •and/or registered DAAs without evidence of cross-resistance to donor protocol
- •2. Patients participating in DAA SVR durability: treatment with any anti HCV therapy (perceived or known anti-HCV activity) since establishing SVR in the donor study
研究者
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