IRCT201104106161N1已完成4 期
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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- no limit 至 6 years（—）
- 性别
- Male
入选标准
- •1-Male subjects; 2-Any ethnicity; 3-Age <6 years; 4-Severe haemophilia A (FVIII:C <1%), as confirmed by the central laboratory; 5-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; 6-Negative inhibitor measurement at both local and central laboratory at screening; 7-Ability to comply with study requirements; 8-Signed informed consent of legal tutors. Exclusion criteria:
- •1-Plasma FVIII level =1%, as assayed at the central laboratory; 2-Previous history of FVIII inhibitor; 3-Other congenital or acquired bleeding defects; 4-Concomitant congenital or acquired immunodeficiency; 5-Concomitant treatment with systemic immunosuppressive drugs; 6-Concomitant treatment with any investigational drug.
排除标准
- 未提供
研究者
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Development of antibody against FVIII (inhibitors) in Untreated Patients or Minimally Blood Component-Treated Patients when Exposed Factor concentrates which can be made from human blood (plasma-derived) or manufactured in laboratory using genetically engineered cells that carry a human factor gene (recombinant): A non-commercial, international study with lots of sites and it is known which of the two by random assigned drugs will be takeInhibitor 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 TrialMedDRA version: 14.1Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2009-011186-88-DEFONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI300
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Development of antibody against FVIII (inhibitors) in Untreated Patients or Minimally Blood Component-Treated Patients when Exposed Factor concentrates which can be made from human blood (plasma-derived) or manufactured in laboratory using genetically engineered cells that carry a human factor gene (recombinant): A non-commercial, international study with lots of sites and it is known which of the two by random assigned drugs will be takeInhibitor 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 TrialMedDRA version: 16.1Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 100000004850EUCTR2009-011186-88-SKFONDAZIONE ANGELO BIANCHI BONOMI300
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