NCT01708564已完成1 期
A Phase 1b, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Factor VIIa concentration in patient plasma as measured by FVIIa PK and PD assays
研究概览
简要总结
This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose levels. The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with rhFVIIa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •be male with a diagnosis of moderate or severe congenital hemophilia A and/or B (with or without inhibitors)
- •be 18 years or older, up to and including 75 years of age
- •be capable of understanding and willing to comply with the conditions of the protocol
- •have read, understood and provided written informed consent
排除标准
- •have any coagulation disorder other than hemophilia A or B
- •have a body weight >105 kg (231 lb)
- •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)
- •have a known allergy or hypersensitivity to rabbits
- •have platelet count <100,000/mL
- •have had within one month prior to first administration of the study drug in this study a major surgical procedure (e.g. orthopedic, abdominal)
- •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
- •have received a Factor VII or FVIIa containing product (either plasma derived or recombinant) within 72 hours prior to any study drug administration
- •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
- •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)
- •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)
- •use any anticoagulant for arterial/venous obstructions and/or atrial fibrillation within 7 days prior to first study drug administration
- •have an active malignancy (those with non-melanoma skin cancer are allowed)
- •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
研究组 & 干预措施
Cohort 3
Experimental
10 patients administered a single high dose of rhFVIIa
干预措施: rhFVIIa (Biological)
Cohort 2
Experimental
10 patients administered a single intermediate dose of rhFVIIa
干预措施: rhFVIIa (Biological)
Cohort 1
Experimental
10 patients administered a single low dose of rhFVIIa
干预措施: rhFVIIa (Biological)
结局指标
主要结局
Factor VIIa concentration in patient plasma as measured by FVIIa PK and PD assays
时间窗: Up to 36 hours of dosing
次要结局
- Incidence of patients with treatment emergent adverse events(Up to 28 days after dosing)
研究者
研究点 (3)
Loading locations...
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