NCT01599819已完成1 期
BAX 855 (PEGylated Recombinant Factor VIII): A Phase 1, Prospective, Open Label, Cross-Over, Dose-Escalation Study in Previously Treated Patients (PTPs) With Severe (FVIII < 1%) Hemophilia A
Baxalta now part of Shire16 个研究点 分布在 4 个国家目标入组 19 人开始时间: 2011年9月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 16
- 主要终点
- Serious and non-serious AEs
研究概览
简要总结
The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subject is male and is 18 to 65 years of age at the time of screening
- •The subject has severe hemophilia A (factor VIII level < 1%)
- •The subject was previously treated with plasma-derived factor VIII (FVIII) concentrates or recombinant FVIII for at least 150 exposure days (EDs)
排除标准
- •The subject has a detectable FVIII inhibitor at screening, with a titer >= 0.6 BU
- •The subject has a documented history of FVIII inhibitors with a titer >= 0.4 BU at any time prior to screening
- •The subject has a known hypersensitivity towards mouse or hamster proteins or to polyethylene glycol (PEG)
结局指标
主要结局
Serious and non-serious AEs
时间窗: 4 weeks after infusion with BAX 855 and ADVATE
次要结局
未报告次要终点
研究者
研究点 (16)
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