RECRUITINGOBSERVATIONAL
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)
About This Trial
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)
Who May Be Eligible (Plain English)
Who May Qualify:
1. Patients with severe hemophilia A (all ages).
2. Patients with moderate type hemophilia A with hemophilic arthropathy.
3. Currently on rFVIIIFc regular prophylaxis and have previous medical record with regular prophylaxis with standard half-life product for one year
4. Able and willing to undergo joint and bone examinations
Who Should NOT Join This Trial:
1. Participants of other interventional studies.
2. Patients with current inhibitors.
3. History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
4. History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
5. Significantly impaired vision/hearing
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Patients with severe hemophilia A (all ages).
2. Patients with moderate type hemophilia A with hemophilic arthropathy.
3. Currently on rFVIIIFc regular prophylaxis and have previous medical record with regular prophylaxis with standard half-life product for one year
4. Able and willing to undergo joint and bone examinations
Exclusion Criteria:
1. Participants of other interventional studies.
2. Patients with current inhibitors.
3. History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
4. History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
5. Significantly impaired vision/hearing
Treatments Being Tested
DIAGNOSTIC_TEST
serum biomarker.
serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)
Locations (1)
Tri-Service General Hospital Hemophilia Care Center
Taipei, Neihu Dist., Taiwan