EUCTR2009-011186-88-PT进行中（未招募）不适用
Inhibitor Development in Previously Untreated Patients (PUPs) or Minimally Blood Component-Treated Patients (MBCTPs) when Exposed to plasma-derived von Willebrand Factor-Containing Factor VIII (VWF/FVIII) Concentrates and to Recombinant Factor VIII (rFVIII) Concentrates: An Independent, International, Multicentre, Prospective, Controlled, Randomised, Open Label, Clinical Trial - SIPPET
FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI0 个研究点目标入组 300 人开始时间: 2009年9月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •Male subjects
- •Any ethnicity
- •Age <6 years
- •Severe haemophilia A (FVIII:C <1%), as confirmed by the central laboratory
- •oPatients with FVIII levels >1% and < 2% will be separately recorded in the screening list
- •Previously untreated (0 EDs to any FVIII concentrate or blood products) or minimally treated (<5 EDs) with blood components, namely whole blood, fresh frozen plasma, packed red blood cells, platelets or cryoprecipitate
- •oPatients not meeting these criteria will be separately recorded in the screening list
- •Negative inhibitor measurement at both local and central laboratory at screening
- •Ability to comply with study requirements
- •Signed informed consent of legal tutors
- •oPatients who will not accept to enter into the study or to be randomized will be separately recorded
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) no
- •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
- •Plasma FVIII level =1%, as assayed at the central laboratory
- •oThose patients originally diagnosed locally as severe but subsequently found to have FVIII levels ranging from 1% to 2% on testing at the central laboratory will be separately recorded in the screening list.
- •Previous history of FVIII inhibitor
- •Other congenital or acquired bleeding defects
- •Concomitant congenital or acquired immunodeficiency
- •Concomitant treatment with systemic immunosuppressive drugs
- •Concomitant treatment with any investigational drug
研究者
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