EUCTR2012-001309-26-IT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. - CSL689_2001
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
- 25
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 (BU)/mL.
- •4. Body weight =100 kg.
- •5. Written informed consent for study participation obtained from the subject or the subject’s legally acceptable representative (as appropriate) before undergoing any study-specific procedures.
- •Are the trial subjects under 18? yes
- •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 53
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Congenital or acquired coagulation disorders other than hemophilia A or B.
- •2. Ongoing immune tolerance induction therapy or planned immune tolerance induction therapy during the study period until the last follow-up visit.
- •3. Known or suspected hypersensitivity to any excipient of CSL689.
- •4. Known or clinically suspected allergy to activated recombinant human FVII.
- •5. Known active pseudotumors.
- •6. Body mass index >30 kg/m².
- •7. Platelet count <50,000 platelets/µL.
- •8. Major surgery within 28 days before screening (catheter, stents, dental procedures, and port insertion are acceptable).
- •9. Scheduled major and / or orthopedic surgery during the study period through follow-up visit.
研究者
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