EUCTR2005-004435-22-FR进行中（未招募）不适用
Incidence of inhibitors in previously untreated patient with severe haemophilia A treated with Octanate (Phase III) - Etude AVI 4-03
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
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
- All
入选标准
- •- Patient n'ayant pas été préalablement traité pour une hémophilie A sévère (F VIII: C < 2%).
- •- Patient pouvant être suivi et traité régulièrement dans le centre d'investigation.
- •- Patient n'ayant pas été préalablement traité par un facteur VIII recombinant ou d'origine plasmatique.
- •- Patient n'ayant pas montré une activité de l'inhibiteur avant son admission (seuil : 0.6 B.U).
- •- Consentement éclairé obtenu du patient ou du parent du patient ou de son représentant légal.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •- Patient ayant des troubles hémorragiques définis, autre que l'hémophilie A (e.g. maladie de von Willebrand).
- •- Patient avec une concentration de Facteur VIII supérieure à 2%.
- •- Patient nécéssitant une thérapie par Interféron.
- •- Participation à une autre étude clinique, actuellement ou au cours des 4 précédentes semaines.
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate if switching from plasma-derived factor VIII products to recombinant factor VIII products lead to an increased inhibitor development in patients with hemophilia AEUCTR2017-005197-19-ITFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO200
进行中（未招募）
不适用
INCIDENCE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEAMOPHILIA A TREATED WITH OCTANATE - AVI-40-3EUCTR2005-004435-22-CZOCTAPHARMA AG35
进行中（未招募）
不适用
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
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 TrialInhibitor 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: 100000004850EUCTR2009-011186-88-PTFONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI300
进行中（未招募）
不适用
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 takeEUCTR2009-011186-88-ATFONDAZIONE ANGELO BIANCHI BONOMI300