EUCTR2009-016560-36-PL进行中（未招募）不适用
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)
试验速览
- 阶段
- 不适用
- 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
- •XML File Identifier: W5hnjkW929pvMl4ur4Sr0EeQesE=
- •(see definitions in Appendix 1) not associated with selection of S282T
- •mutations or any newly identified mericitabine resistance mutation(s),
- •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
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 PEGIFN/
- •and/or registered DAAs without evidence of cross-resistance to donor
- •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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