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临床试验/EUCTR2008-005826-35-IT
EUCTR2008-005826-35-IT进行中(未招募)不适用

A multicenter, double-blind, extension trial of two parallel dose groups of Plant cell expressed recombinant human glucocerebrosidase (prGCD) in patients with Gaucher disiease. - PB-06-003

PROTALIX BIOTHERAPEUTICS0 个研究点目标入组 30 人开始时间: 2009年6月30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
30

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

  • Completion of Protocol PB-06-001
  • The patient signs an informed consent
  • 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

  • Currently taking another experimental drug for any condition
  • Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease
  • Pregnant or nursing
  • Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient?s compliance with the requirements of the study.

研究者

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