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临床试验/EUCTR2011-006132-24-GB
EUCTR2011-006132-24-GB进行中(未招募)1 期

A multi-centre 3-year follow-up study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored alisporivir studies for chronic hepatitis C patients

ovartis Pharma Services AG0 个研究点目标入组 105 人开始时间: 2012年5月10日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
105

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

  • -Written informed consent must be obtained before any assessment is performed
  • -Males or females aged 18 or greater
  • -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent
  • -Have not acheived SVR24
  • -Are able to comply with visit schedule
  • 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 650
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer
  • -Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

研究者

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