EUCTR2012-002554-23-PT进行中（未招募）1 期
Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII in Previously Untreated Patients with Severe Haemophilia A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •In order to qualify for study enrolment, the following criteria must be fulfilled before study entry:
- •1. Male patients
- •2. Severe haemophilia A (FVIII:C < 1%)
- •3. No previous treatment with FVIII concentrates or other blood products containing FVIII
- •4. Voluntarily given, fully informed written and signed consent given before any study related procedures are conducted (obtained from the patient’s parent(s)/legal guardian(s))
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients will not be included if any of the following exclusion criteria are met:
- •1. Diagnosis of a coagulation disorder other than haemophilia A
- •2. Severe liver or kidney disease (ALT or AST levels >5 times of upper limit of normal (ULN), creatinine >120 µmol/L)
- •3. Concomitant treatment with any systemic immunosuppressive drug
- •4. Participation in another interventional clinical study currently or during the past
研究者
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