EUCTR2010-021781-29-IT进行中（未招募）1 期
A multicenter Phase III uncontrolled open-label trial to evaluate safety and efficacy of BAY 81-8973 in children with severe haemophilia A under prophylaxis therapy - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
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
- •Part A 1. Male, aged = 12 years 2. Severe hemophilia A defined as < 1% factor VIII concentration (FVIII:C) based on medical records and/or screening laboratory 3. > 50 ED with any high purity FVIII; 4. No current evidence of inhibitor antibody measured using the Nijmegen modified Bethesda assay [<0.6 Bethesda units (BU)/mL] within 2-3 week after last administration. Subjects may not receive FVIII within 48 h prior to the collection of samples for inhibitor testing. 5. No history of FVIII inhibitor formation. Documentation of negative result in medical records required, except for PUPs. [Subjects with a maximum historical titer of 1.0 BU on no more than 1 occasion with the classical Bethesda assay but at least 3 successive negative (<0.6 BU) results thereafter are eligible.] 6. Willingness and ability of subjects and/or parents to complete training in the use of the study electronic patient diary (EPD) and to document injection information during the study. 7. Written informed consent by parent/legal representative. Assent should be sought from subjects if appropriate Part B (PUPs) 8. Inclusion of PUPs may start after 10 children have accumulated 50 ED 9. Male, aged = 6 years 10. Severe hemophilia A defined as < 1% FVIII:C based on medical records and/or screening laboratory 11. no previous exposure to any FVIII 12. PUPs may be included if they will receive their first FVIII dose as regular prophylaxis or on-demand treatment for bleedings, and are willing to continue with prophylaxis. 13. Written informed consent by parent/legal representative
- •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
- •Part A and B 1. Any individuals with another bleeding disease that is different from Hemophilia A (eg, von Willebrand disease, Hemophilia B) 2. Any individual with thrombocytopenia (platelet count < 100 000/mm3) based on medical records or screening laboratory 3. Any individual with abnormal renal function (serum creatinine > 2.0 mg/dL) based on medical records or screening laboratory 4. Any individual without any documented negative inhibitor test (except for PUPs) 5. Any individual who is receiving or has received other experimental drugs within 3 months prior to study entry or has participated in a FVIII study within the last month 6. Any individual who requires any pre-medication to tolerate FVIII injections (eg, antihistamines) 7. Any individual who is unwilling to comply with study visits or other protocol requirements, for example (eg) prophylaxis treatment or is not suitable for participation in this study for any reason, according to the Investigator 8. Known hypersensitivity to active substance, mouse or hamster protein. 9. Previous participation in this study Part B only 10. For PUPs: first treatment with BAY 81-8973 for surgery
研究者
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