An Investigator-sponsored study on rFVIIa prophylaxis in children with haemophilia A and inhibitorsEstudio promovido por el investigador sobre profilaxis con rFVIIa en niños con hemofilia A e inhibidores - ENJOIH 01

Elena Santagostino0 个研究点目标入组 50 人开始时间: 2009年6月25日最近更新: 2013年8月26日

适应症

试验速览

暂无简介。

•- Patients with haemophilia A who have been treated with factor VIII on-demand or on prophylaxis and who have developed inhibitors to factor VIII.
•- Age < 8 years.
•- = or < 2 years from the time of first inhibitor detection.
•- High-responding inhibitors (historical peak > 5 BU/mL) and known anamnestic response in case of negative inhibitor titre.
•- Candidates to start ITI.
•- Maximal two bleedings in the same joint within the last 6 months before entering the study or maximal six joint bleeds in the same joint within 2 years.
•- Adequate venous access for daily infusion and capable (patient or guardian) of reconstituting and injecting the study drug (as judged by the nvestigator).
•- Informed consent by parents or guardians.
•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

•- ITI already started.
•- Known or suspected allergy to the study drug or any of its components.
•- Administration of any investigational product within 30 days prior to randomisation.
•- Other coagulation disorders than congenital haemophilia A.
•- Family history of thrombosis at an early age (< 40 years), known thrombophilia, any previous thrombosis including catheter-related deep
•vein thrombosis, previous neonatal thrombosis.
•- Known pseudo tumours.
•- Known severe liver disease.
•- Platelet count < 50,000 platelets/mcL at screening.
•- Surgery within one month or planned major and/or orthopaedic surgery.

发起方

Elena Santagostino