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临床试验/EUCTR2010-023669-23-SK
EUCTR2010-023669-23-SK进行中(未招募)1 期

Multicenter, Open-Label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis

Janssen-Cilag International NV0 个研究点目标入组 1,772 人开始时间: 2011年10月6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
1,772

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. Patient must have evidence of chronic Hepatitis C (genotype 1) infection.
  • 2. Patient must have documentation of liver fibrosis assessed by liver biopsy or noninvasive test showing severe fibrosis or cirrhosis
  • 3. Evidence of compensated liver disease
  • 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 48
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • 1. Patient is infected or co-infected with HCV of another genotype than genotype 1
  • 2. Patient has signs or symptoms of HCC
  • 3. Patient has a history of decompensated liver disease
  • 4. Patient has a co-infection with active hepatitis B or HIV

研究者

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