EUCTR2008-005825-12-Outside-EU/EEA进行中（未招募）不适用
A multi-centre, open-label, switchover trial to assess safety and efficacy of taliglucerase alfa in adult and paediatric patients with Gaucher disease who are currently being treated with imiglucerase enzyme replacement therapy (ERT).
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
- •Males and females, 2 years or older
- •Confirmed diagnosis of Gaucher disease by the enzymatic activity assay
- •Stable Gaucher disease
- •Treatment with imiglucerase (Cerezyme®) for at least 2 years and on a stable maintenance regimen (dose and regimen unchanged, except for situation of drug shortage) for at least the last six months
- •Able to provide written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •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
- •History of allergy to carrots
- •History of allergy to beta lactam antibiotics
- •Previous infusion reaction suspected to be allergic in nature to Cerezyme® or Ceredase® or receiving premedication to prevent infusion reactions
- •Presence of HIV and/or HBsAg and/or hepatitis C infection
- •Presence of unresolved anemia due to iron, folic acid or vitamin B12 deficiency
- •Presence of any significant comorbidity that could confound the interpretation of the clinical response to taliglucerase alfa
- •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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