EUCTR2011-001785-17-GB进行中（未招募）1 期
Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII - GENA-13
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Evaluable completion of 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Development of FVIII inhibitors (=0.6 Bethesda units [BU]) in the course of study GENA-03.
- •2.Any severe liver or kidney disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >5 times of upper limit of normal, creatinine >120 µmol/L).
研究者
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