RecruitingNot Applicable

A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)

Taiwan45 participantsStarted 2023-07-14

Plain-language 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)

Who can participate

SexMALE

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Systematic joint and bone health assessments before and after enrollment

Timeframe: up to 5 years

Trial details

NCT IDNCT05981274

SponsorTri-Service General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Yeu-Chin Chen

(+886)2-87923311 yeuchin99@gmail.com

View on ClinicalTrials.gov More Severe Hemophilia A Without Inhibitor trials