To compare the effectiveness of standard weight based dosing of Factor VIII prophylaxis against regimens using an individual's own rate of Factor VIII clearance in adult patients with severe Factor VIII deficiency (Haemophilia A).

Conditions: Severe Haemophilia A
MedDRA version: 14.1Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 100000004850
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2013-003240-23-IE

Lead Sponsor: St. James' Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

•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

•Prisoners

•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.