NCT00056589已完成1 期
A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documental congenital FXIII deficiency
- •Normal platelet count and clotting parameters
- •Adequate renal and hepatic function
- •If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment
- •If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
- •Negative drug and alcohol screens
排除标准
- •Received blood products or FXIII concentrates within 4 weeks of study enrollment
- •Known antibodies to FXIII
- •Hereditary or acquired coagulation disorder other than FXIII deficiency
- •Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus
- •Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment
- •Received treatment with any experimental agent within 30 days of study enrollment
- •Any surgical procedure in the 30 days prior to enrollment
- •Donated blood within 30 days prior to enrollment
研究组 & 干预措施
rFXIII
Experimental
干预措施: catridecacog (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Days 0-28
次要结局
- Incidence of clinically significant changes from baseline in physical examination or laboratory measurements(Days 0-28)
- Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)(Days 0-28)
- Incidence of yeast antibodies(Days 0-28)
- FXIII activity measured by the Berichrom® assay(Days 0-28)
研究者
研究点 (1)
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