NL-OMON36958已完成不适用
A Phase Ib, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients - NA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. be male with a diagnosis of moderate or severe congenital hemophilia A and/or B (with or without inhibitors);2. be 18 years or older, up to and including 75 years of age;3. be capable of understanding and willing to comply with the conditions of the protocol;4. have read, understood and provided written informed consent
排除标准
- •1. have any coagulation disorder other than hemophilia A or B;2. have a body weight >105 kg (231 lb);3. be immuno-suppressed (i.e., the patient should not receive systemic immunosuppressive medication <30 days prior to enrollment, CD4 counts at screening should be >200/µl);4. have a known allergy or hypersensitivity to rabbits ;5. have platelet count <100,000/mL;6. have had within one month prior to first administration of the study drug in this study a major surgical procedure (e.g. orthopedic, abdominal);7. have an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 24 hours of the time of study drug administration;8. have received a Factor VII or FVIIa containing product (either plasma derived or recombinant) within 72 hours prior to any study drug administration;9. have received an investigational drug within 30 days of the first study drug administration, or is expected to receive such drug during participation in this study;10. have a clinically relevant hepatic (hepatic enzymes >3 times the upper limit of normal) and/or renal impairment (creatinine >2 times the upper limit of normal);11. have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis or pulmonary embolism) within 2 years prior to first dose of study drug, have an arterial stent in place or have clinically significant atherosclerotic disease (e.g., angina pectoris, peripheral vascular disease);12. use any anticoagulant for arterial/venous obstructions and/or atrial fibrillation within 7 daysprior to first study drug administration;13. have an active malignancy (those with non-melanoma skin cancer are allowed);14. have any life-threatening disease or other disease or condition which, according to the investigator*s judgment, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
研究者
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