NL-OMON45210已完成3 期
A multi-center, phase III, non-controlled, open-label trial to evaluate the pharmacokinetics, safety, and efficacy of BAY 94-9027 for prophylaxis and treatment of bleeding in previously treated children (age < 12 years) with severe hemophilia A. - PROTECT KIDS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •- Males < 12 years of age
- •- Subjects with severe hemophilia A
- •- Previously treated with FVIII for > 50 exposure days
- •- Subjects in the expansion group < 6 years of age
排除标准
- •- Subjects with current evidence of or history of inhibitors to FVIII
- •- Any other inherited or acquired bleeding disorder
- •- Platelet counts < 100,000/mm^3
- •- Creatinine > 2x the upper limit of normal
- •- Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) > 5x the upper limit of normal
研究者
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