EUCTR2010-021781-29-ES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 - Leopold Kids
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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, age <= 12 years. Enrollment will begin with subjects 6-12 years before it is opened to all age groups.
- •2. Severe hemophilia A defined as < 1% factor VIII concentration (FVIII:C) based on documented prior testing or screening laboratory
- •3. >/= 50 ED with any FVIII concentrate
- •4. No current evidence of inhibitor antibody measured using the Nijmegen modified Bethesda assay [<0.6 Bethesda units (BU)/mL] within 2-3 weeks of last FVIII administration.
- •5. No history of FVIII inhibitor formation. Documentation of negative result in medical records required. [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 electronic patient diary (EPD) and to document infusions during the study.
- •7. Written informed consent by parent/legal representative. Assent should be sought from subjects if appropriate
- •Part B (PUPs)
- •1. Male, < 6 years
- •2. Severe hemophilia A defined as < 1% FVIII:C based on prior documented testing or confirmed on screening laboratory
- •3. No previous exposure to any FVIII product
- •4. PUPs may be included if they will receive their first FVIII dose with BAY 81-8973 for treatment of first bleeds and agree to start prophylaxis as part of their care.
- •5. Willingness and ability of parents to complete training in the use of the electronic patient diary (EPD) and to document all treatment during the study.
- •6. Written informed consent by parent/legal representative.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •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
- •Parts A and B
- •1. Any individual with another bleeding disorder that is different from Hemophilia A (eg, von Willebrand disease, Hemophilia B)
- •2. Any individual with thrombocytopenia (platelet count < 100,000/mm3)
- •3. Creatinine > 2x upper limit of normal or AST/ALT > 5x upper limit of normal
- •4. Any individual without a negative inhibitor at screening (except for PUPs)
- •5. Any individual who is receiving chemotherapy, immune modulatory drugs (IVIG, cyclosporine, chronic use of oral or i.v. corticosteroids), has received another investigational FVIII product within the last month, or received another experimental drug within the last 3 months.
- •6. Any individual who requires any pre-medication to tolerate FVIII treatment (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's judgment.
- •8. Known hypersensitivity to active substance, mouse or hamster protein.
- •9. Previous participation in this study
- •Part B only (PUPs):
- •10. First treatment with BAY 81-8973 for high risk bleeding situations (e.g. surgery, intracranial bleed), or requiring intensive or prolonged treatment.
- •11. Unable to tolerate volume of blood draws required for study participation.
研究者
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