NCT01341912已完成3 期
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
- 3 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Long-term Immunogenicity
研究概览
简要总结
The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
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 enrollment into GENA-11
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 level > 5 times of upper limit of normal, creatine >120 micro mol/L) during the course of the GENA-01 study
结局指标
主要结局
Long-term Immunogenicity
时间窗: up to 3 years
Patients will be monitored for inhibitors against FVIII every 3 months. Blood samples were drawn and inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) in the central lab.
次要结局
- To Determine Long-term Efficacy of Human-cl rhFVIII in the Treatment of Bleeding Episodes and in Surgical Prophylaxis(up to 3 years)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on GingivitisGingivitisNCT01811316Sunstar Americas62
进行中（未招募）
3 期
Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia VeraPolycythemia VeraNCT06033586Protagonist Therapeutics, Inc.46
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-01Severe haemophilia A (FVIII:C <1%)MedDRA version: 12.1Level: LLTClassification code 10018937Term: Haemophilia AEUCTR2010-023242-69-DEOctapharma AG25
Unknown
不适用
Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than RisperidoneSchizophrenia, CatatonicSchizophrenia, DisorganizedSchizophrenia, ParanoidPsychotic DisordersSchizophreniaNCT00563017Hospital Authority, Hong Kong30
Unknown
早期 1 期
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive DisorderObsessive-Compulsive DisorderNCT02253472Beijing Pins Medical Co., Ltd30