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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorTri-Service General Hospital

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

severe hemophilia A patients or moderate hemophilia A patients with hemophilic arthropathy.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • serum biomarker.

    Diagnostic test

    serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Systematic joint and bone health assessments before and after enrollment1 intervention

Trial outcomes

Primary outcomes

1

Systematic joint and bone health assessments before and after enrollment

Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) on patients' ankles, knees, and elbows. Also evaluate the Hemophilia Joint Health Score (HJHS) and Dexa scan at the hip.

Time frame
up to 5 years

Secondary outcomes

1

Serum markers

CTX-II, COMP, HSCRP, TNF-ALPHA, CTX-I, SRANKL, OPG, OPN

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

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