A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)
A Prospective and Retrospective Interventional Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)
Tri-Service General Hospital
45 participants
Jul 14, 2023
OBSERVATIONAL
Conditions
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. 3. Compare the clinical outcomes from 1 year before and after switching to EHL. 4. Exploratory: Identify biomarkers that could provide more useful and convenient evaluations of joint and bone health. (Time-saving and easy to monitor)
Eligibility
Inclusion Criteria4
- 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 Criteria5
- 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
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Interventions
serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05981274