EUCTR2012-001309-26-ES进行中（未招募）1 期
A multicenter, open-label, multiple-dose, dose escalation study to investigate the pharmacokinetics, efficacy, and safety of rVIIa-FP (CSL689) in subjects with hemophilia (A or B) and inhibitors.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
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 subjects with hemophilia A or B and inhibitors.
- •2. Age ? 12 and ? 65 years.
- •3. High responding inhibitor with documented historical inhibitor titer > 5 Bethesda Units/mL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Congenital or acquired coagulation disorders other than hemophilia A or B.
- •2. Ongoing immune tolerance induction therapy or planned during study.
- •3. Known or suspected hypersensitivity to activated recombinant human FVII or to any excipient of CSL689.
- •4. Body mass index > 30 kg/m².
- •5. Major surgery within 28 days before screening or scheduled major and / or orthopedic surgery during the study.
- •6. Advanced atherosclerotic disease (ie, known history of ischemic heart disease, or ischemic stroke).
- •7. Any clinical signs or known history of thromboembolic events, including known deep vein thrombosis.
- •8. Human immunodeficiency virus (HIV)-positive subjects who have low cluster of differentiation 4 (CD4)+ lymphocyte count (200/?L or less) at screening.
- •9. Use of the following within the screening period and planned during study: a) plasma or coagulation factor concentrates other than rescue therapy or therapy during the PK Module, b) other platelet inhibitors, c) desmopressin, and d) fibrinolysis inhibitors (except if used as local treatment (eg, for oral bleeds).
研究者
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