EUCTR2017-005197-19-IT进行中（未招募）1 期
Inhibitor development in previously untreated patients with severe haemophilia A, first treated with plasma-derived factor VIII and then switched to recombinant product: an international, multicentre, prospective, controlled, randomized, open label, clinical trial - Risk of inhibitor development after 50 exposure days to factor VIII
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
入选标准
- •1. Male subjects
- •2. Any ethnicity
- •3. Age < 6 years
- •4. Severe haemophilia A (FVIII:C < 1% as confirmed at enrolment by the central laboratory (those patients diagnosed locally as severe but subsequently found to have measurable FVIII ( = 1%) will be considered screening failure).
- •5. Previously untreated patients (0 ED to any FVIII concentrates or blood products) or minimally treated (< 5 EDs) with blood components (whole blood, packed red blood cells, platelets, cryoprecipitate or fresh frozen plasma)
- •6. Negative inhibitor measurement at both local and central laboratory at screening, i.e., before any treatment with a FVIII concentrate
- •7. Ability to comply with study requirements
- •8. Signed informed consent of legal tutors
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •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
- •1. Previous history of inhibitor
- •2. Other congenital or acquired bleeding defects
- •3. Plasma FVIII level = 1% as assayed at the central laboratory. Patients diagnosed locally as severe and not confirmed by the central evaluation will be considered screening failure and excluded from the study.
- •4. Concomitant congenital or acquired immunodeficiencies
- •5. Concomitant treatment with systemic immunosuppressive drugs
研究者
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