NCT02263469已完成3 期
An Open Multi-centre Phase III Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients Under the Age of 6 Years
Bio Products Laboratory6 个研究点 分布在 2 个国家开始时间: 2005年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 6
- 主要终点
- Amount of Factor IX Administered per Month (IU/KG)
研究概览
简要总结
The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.
排除标准
- 未提供
研究组 & 干预措施
Replenine®-VF
Experimental
干预措施: Replenine®-VF (High Purity Factor IX) (Biological)
结局指标
主要结局
Amount of Factor IX Administered per Month (IU/KG)
时间窗: 26 Weeks
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
Phase III B in Acute Lymphoblastic LeukemiaAcute Lymphoblastic LeukemiaNCT03123939Novartis Pharmaceuticals69
已完成
3 期
Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of AgeSeasonal InfluenzaNCT01209780Novartis Vaccines3,116
已完成
3 期
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)Pneumococcal InfectionsNCT03731182Merck Sharp & Dohme LLC104
已完成
3 期
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia ASevere Hemophilia AHemophilia ANCT02172950CSL Behring246
已完成
2 期
Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in ChildrenInfluenzaNCT00502593GlaxoSmithKline138