PERSONALising Factor VIII prophylaxis regimens: Efficacy of standard versus pharmacokinetically based regimens in adult patients with severe Haemophilia A (PERSONAL trial) - PERSONAL trial

St. James' Hospital0 个研究点开始时间: 2013年10月10日最近更新: 2015年9月7日

适应症

试验速览

暂无简介。

•Severe Haemophilia A (baseline Factor VIII level of <1 IU/dL)
•Age 18 years and above
•Patients taking any regular prophylactic regimen (defined
•as regular factor VIII infusions, at least 5 times a fortnight, with the aim of minimising haemarthroses and other clinically significant bleeds).
•Low titre inhibitors, past history of an inhibitor, abnormal liver function, drugs that interfere with haemostasis and low CD4 counts are allowed.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 38
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Presence of a target joint on prophylaxis (defined as 3 bleeds into one joint, during a 6 month period, during the last year).
•The occurrence of more than 3 haemarthroses in the last year which required more than 2 infusions to resolve.
•Pregnant or breastfeeding women
•Patients with a learning disability or dementia
•Adults who are unconscious/unable to give informed consent
•Participants with a pacemaker or implanted medical devices which are unsuitable to have a MRI will be excluded from the MRI scans during the trial but may proceed with other components.

发起方

St. James' Hospital