NCT00157053已完成2 期
Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study
Baxalta now part of Shire46 个研究点 分布在 9 个国家目标入组 82 人开始时间: 2001年11月22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
- 82
- 试验地点
- 46
- 主要终点
- Terminal phase half-life for 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 safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has completed Baxter protocol 069901
- •Subject is HIV-1 seronegative or, if HIV-1 seropositive, has a CD4+ lymphocyte count >= 400/mm3 documented within three months of the screening visit
- •Subject (and his legally acceptable representative, in the case of study participants >= 10 and < 18 years of age) has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter
排除标准
- •The subject received factor VIII products other than rAHF-PFM upon completion of Baxter protocol 069901
- •The subject developed an inhibitor to factor VIII, measured in the central laboratory, during Baxter protocol
- •An inhibitor is defined as a Bethesda titer > 1.0 or, if Bethesda titer < 1.0, confirmation using the Nijmegen modification of the Bethesda assay with a titer > 0.6
- •The subject is scheduled to receive an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids) during the course of the study
- •The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
结局指标
主要结局
Terminal phase half-life for 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.
次要结局
未报告次要终点
研究者
研究点 (46)
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