NCT00618579已完成1 期
A Randomised, Controlled Study Investigating the Safety and Anticoagulant Activity of Administration of Low-molecular-weight Heparin in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402 and the Safety and Anticoagulant Activity of Administration of TB-402 in Healthy Male Subjects Treated With Warfarin
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
- 15
- 试验地点
- 1
- 主要终点
- Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c
研究概览
简要总结
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LMWH arm - active LMWH
Experimental
干预措施: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects (Drug)
LMWH arm - placebo
Placebo Comparator
干预措施: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects (Drug)
Warfarin arm - active warfarin
Experimental
干预措施: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects (Drug)
Warfarin arm - control
Other
干预措施: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects (Drug)
结局指标
主要结局
Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c
时间窗: To study end
次要结局
- Changes in safety parameters over time, PK parameters estimated by NCA, effect of LMWH in TB-402 treated subjects assessed by anti factor Xa (LMWH arm)(To study end)
研究者
研究点 (1)
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