EUCTR2010-018644-14-GB进行中（未招募）不适用
PROSPECTIVE CLINICAL STUDY IN CHILDREN WITH SEVERE HAEMOPHILIA A TO INVESTIGATE CLINICAL EFFICACY, IMMUNOGENICITY, PHARMACOKINETICS, AND SAFETY OF HUMAN-CL RHFVIII - GENA-03
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- Male
入选标准
- •? Severe haemophilia A (FVIII:C < 1%)
- •? Age >= 2 and < 13
- •? Previously treated with FVIII concentrate, at least 50 EDs
- •? Immunocompetence (CD4+ count >200/ µL)
- •? HIV negative or respective viral load < 200 particles/µL or <400,000 copies/ml
- •? Freely given written informed consent by parents or legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •? Other coagulation disorder than haemophilia A
- •? Present or past FVIII inhibitor activity (= 0.6 BU)
- •? Target joints
- •? Severe liver or kidney disease (ALT and AST levels >5 times of upper limit of normal, creatinine >120 µmol/L)
- •? Receipt or scheduled receipt of immuno-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (>10 mg/day), or comparable drugs
- •? Current participation in another clinical study
- •? Participation in another interventional clinical study with administration of investigational medical product (IMP) in the course of the past 3 months, except studies investigating already registered FVIII products
研究者
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