ISRCTN99606748已完成未知
Clinical study in which the immunogenicity, tolerability and efficacy of Human-cl rhFVIII is investigated in children with severe haemophilia A, who were previously treated in the GENA-03 study
Octapharma AG (Switzerland)0 个研究点目标入组 60 人开始时间: 2012年1月3日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26370328
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Evaluable completion of the preceeding study GENA-03 by having a study participation period of 6 months, provided that prophylaxis with Human-cl rhFVIII is continued without intermediate interruption
- •2. Voluntarily given, fully informed written and signed consent obtained from the parents (or legal guardians) before any study-related procedures are conducted. The need for obtaining assent will depend on the subjects' developmental stage and intellectual capacity
- •3. Capability to understand and comply with the relevant aspects of the study
排除标准
- •1. Development of FVIII inhibitors (³0.6 Bethesda Units [BU]) in the course of the GENA-03 study
- •2. Any severe liver or kidney disease (ALT and AST levels >5 times of upper limit of normal, creatinine >120 µmol/L)
研究者
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