Subclinical Joint Bleeding in Irish Adults With Severe Haemophilia A on Personalised Prophylaxis Regimens

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is designed to assess if there is evidence of subclinical joint bleeding on MRI/X-Ray in adults with severe Haemophilia A while on standard and/or pharmacokinetically tailored prophylaxis regimens. Participants with severe Haemophilia A will have longitudinal MRI and XRay imaging of their elbows, ankles and knees at 0, 6 and 18 months while on standard ( 0-6 months) and then pharmacokinetically tailored (7-18 months) recombinant Factor VIII prophylaxis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. James's Hospital, Ireland
• Collaborator: Baxter BioScience
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Male patients with severe Haemophilia A (baseline Factor VIII level of <0.01 IU/mL)

• 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 Cluster of Differentiation 4 (CD4) counts are allowed.

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 that required more than 2 infusions to resolve.

• 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.