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临床试验/EUCTR2014-001249-26-ES
EUCTR2014-001249-26-ES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

Gilead Sciences, Inc.0 个研究点目标入组 1,609 人开始时间: 2015年6月15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)
入组人数
1,609

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 previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon;
  • 3) Have achieved SVR in a Gilead-sponsored study, as defined in the treatment protocol;
  • 4) Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen.
  • 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 1700
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 300

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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