EUCTR2010-021781-29-SE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
- 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
- •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
- •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
- •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
- •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
- •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
- •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
- •11.Unable to tolerate volume of blood draws required for study
- •participation.
研究者
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