EUCTR2014-001249-26-DE进行中（未招募）1 期
A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection in Gilead-Sponsored Trials
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
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) Willing and able to provide written informed consent;
- •2) Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon; OR At pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These subjects must have documentation of the regimen, start and end of treatment dates (month and year), and of
- •having achieved SVR12
- •3) Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol; OR for subjects who enroll after receiving an alloral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment.
- •4) Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen; OR Subjects who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis as diagnosed prior to initiation of HCV Treatment.
- •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 1296
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 311
排除标准
- •1) Subject plans to initiate a new course of HCV therapy, including approved products and any
- •investigational agents, during the course of this Registry;
- •2) History of clinically-significant illness or any other major medical disorder that may interfere
- •with the subject follow-up, assessments or compliance with the protocol.
研究者
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