Status:
RECRUITING
A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)
Lead Sponsor:
Tri-Service General Hospital
Conditions:
Severe Hemophilia A Without Inhibitor
Eligibility:
MALE
Brief Summary
Study Objectives\* 1. Provide a systematic evaluation of the treatment outcomes in patients with hemophilia A 2. Emphasize the importance and clinical benefits of rFVIII-Fc in joint and bone health. ...
Detailed Description
In this study, we would like to focus on the evaluation of joint and bone health in persons with severe hemophilia A (PwHA) treated with rFVIIIFc prophylaxis. We also aim to identify potential biomark...
Eligibility Criteria
Inclusion
- Patients with severe hemophilia A (all ages).
- Patients with moderate type hemophilia A with hemophilic arthropathy.
- Currently on rFVIIIFc regular prophylaxis and have previous medical record with regular prophylaxis with standard half-life product for one year
- Able and willing to undergo joint and bone examinations
Exclusion
- Participants of other interventional studies.
- Patients with current inhibitors.
- History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
- History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
- Significantly impaired vision/hearing
Key Trial Info
Start Date :
July 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05981274
Start Date
July 14 2023
End Date
December 31 2027
Last Update
April 10 2024
Active Locations (1)
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1
Tri-Service General Hospital Hemophilia Care Center
Taipei, Neihu Dist., Taiwan, 114202