EUCTR2010-023242-69-DE进行中（未招募）不适用
Clinical Study to Investigate the Long-Term Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients with Severe Haemophilia A – Extension Study to GENA-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
- •Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrolment into GENA-11.
- •Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted.
- •Patient must be capable to understand and comply with the relevant aspects of the study protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Development of FVIII inhibitors (=0.6 BU), during the course of the GENA-01 study.
- •Development of any severe liver or kidney disease (ALT and AST levels >5 times of upper limit of normal, creatinine >120 µmol/L) during the course of the GENA-01 study.
研究者
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