NCT00157040已完成2 期
Recombinant Antihemophilic Factor (rAHF-PFM) Manufactured and Formulated Without Added Human or Animal Proteins: Evaluation of Pharmacokinetics, Immunogenicity, Efficacy and Safety in Previously Treated Pediatric Patients With Hemophilia A
Baxalta now part of Shire24 个研究点 分布在 3 个国家目标入组 50 人开始时间: 2002年6月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 24
- 主要终点
- The terminal phase half-life of Recombinant Antihemophilic Factor (rAHF-PFM)
研究概览
简要总结
The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A. The study consists of 2 parts. Part 1 of the study is a pharmacokinetic evaluation, and Part 2 is an evaluation of efficacy and safety.
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
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is less than 6 years of age
- •Severe or moderately-severe hemophilia A as defined by a baseline factor VIII level <= 2%, documented at screening or on the basis of historical data (e.g., at hemophilia diagnosis)
- •Documented medical history of at least 50 exposure days for treatment with all other factor VIII products
- •Subject's parent or legally authorized representative has provided informed consent
排除标准
- •Detectable inhibitor to factor VIII measured in the screening sample by the local or central hemostasis laboratory
- •History of inhibitor to factor VIII at any time prior to screening
- •Subject has any one of the following laboratory abnormalities at the time of screening:
- •platelet count < 100,000/mm3
- •hemoglobin concentration < 10 g/dL (100 g/L)
- •serum creatinine > 1.5 times the ULN for age
- •total bilirubin > 2 times the ULN for age
- •Subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., platelet dysfunction secondary to uremia, liver failure, von Willebrand's Disease)
- •Subject has known hypersensitivity to RECOMBINATE rAHF
- •Subject is currently participating in another investigational drug study or has participated in any clinical study involving an investigational drug within 30 days of study entry
- •Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
结局指标
主要结局
The terminal phase half-life of Recombinant Antihemophilic Factor (rAHF-PFM)
时间窗: Within 30 minutes prior to the pharmacokinetic infusion and at 1 hour ± 5 minutes, 9 ± 1 hour, 24 ± 2 hours, and 48 ± 2 hours after the infusion
Terminal phase half-life of rAHF-PFM was to be determined using the biphasic linear regression model.
次要结局
未报告次要终点
研究者
研究点 (24)
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