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临床试验/EUCTR2009-011464-11-DE
EUCTR2009-011464-11-DE进行中(未招募)不适用

EXTEND: A 3-Year, Virology, Follow-up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies

Vertex Pharamceuticals, Inc.0 个研究点目标入组 400 人开始时间: 2009年7月29日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
400

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

  • The subject must:
  • 1. Have received at least 1 dose of telaprevir-based treatment in 1 of the following clinical studies: VX05-950-104, VX05-950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, or VX-950-TiDP24-C216.
  • 2. Have baseline HCV viral sequencing data available from previous telaprevir study.
  • 3. Be able and willing to give informed consent to participate in the study.
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • The subject must not:
  • 1. Be currently participating in the antiviral follow-up period of an ongoing telaprevir trial. (Note: Subjects who have completed the required antiviral follow-up period but are still participating in the collection of patient reported outcomes data for their previous telaprevir study may be eligible.)
  • 2. For subjects participating in ongoing studies at the time of enrollment, have more than 90 elapsed days between the database lock or unblinding in the previous telaprevir study and Day 1 in this study.

研究者

发起方
Vertex Pharamceuticals, Inc.

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