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临床试验/EUCTR2013-001141-14-AT
EUCTR2013-001141-14-AT进行中(未招募)不适用

A PHASE 4, BLOOD SAMPLE COLLECTION STUDY FOR EXPLORATORY EVALUATION OF THE ASSOCIATION OF SINGLE NUCLEOTIDEPOLYMORPHISMS WITH TREATMENT RESPONSES FROM SUBJECTS WITH HBEANTIGEN POSITIVE OR NEGATIVE CHRONIC HEPATITIS B, WHO RECEIVED THERAPY FOR HEPATITIS B WITH PEGINTERFERON ALFA-2A 40KD (PEG-IFN) ± NUCLEOS(T)IDE ANALOGUE

F.Hoffmann-La Roche Ltd.0 个研究点目标入组 700 人开始时间: 2013年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
700

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

  • Previously enrolled in a Roche study and treated for CHB for at least 24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entacavir) or Peg-IFN ± nucleotide analogue (adefovir) with =24-week post-treatment follow-up or;
  • Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling who have no contra-indication to Peg-IFN therapy as per the local label and have been
  • treated with Peg-IFN for at least 24 weeks and have =24-week post-treatment response available at the time of blood collection.
  • 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 500
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 200

排除标准

  • Patients infected with HAV, HCV, or HIV

研究者

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