An Investigator-sponsored study on rFVIIa prophylaxis in children with haemophilia A and inhibitors - ENJOIH 01

Dott.ssa Elena Santagostino0 个研究点目标入组 50 人开始时间: 2009年11月30日最近更新: 2013年6月17日

试验速览

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•Male 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. ≤ 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 caregiver) of reconstituting and injecting the study drug (as judged by the Investigator). Informed consent by parents or legal 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 hypersensitivity to the active substance or any of the excipients of the study drug, or to mouse, hamster or bovin protein... 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/?L at screening. Surgery within one month or planned major and/or orthopaedic surgery.

发起方

Dott.ssa Elena Santagostino