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 volunteersQualifiers
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
Other
Other
Treatments tested in this trial
serum biomarker.
Diagnostic testserum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Serum markers
CTX-II, COMP, HSCRP, TNF-ALPHA, CTX-I, SRANKL, OPG, OPN
Sponsors and contacts
Click on the lead sponsor to view all of their trials.