An observational study in Severe Hemophilia A Without Inhibitor, sponsored by Tri-Service General Hospital. Recruiting at 1 site in Taiwan. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Tri-Service General Hospital · Observational
Study Objectives*
In this study, we would like to focus on the evaluation of joint and bone health in persons with severe hemophilia A (PwHA) treated with rFVIIIFc prophylaxis. We also aim to identify potential biomarkers for assessing the joint and bone health of PwHA. Since the joint and bone health examinations are time-consuming, expensive, and require special equipment, the patients could only receive the examinations annually to realize the status of their joint health. The biomarkers testing will provide a more convenient and time-saving option on the joint and bone health evaluation for PwHA. Therefore, surrogate of biochemical marker(s) to represent the joint and BMD progression is an unmet need for clinical practice. Investigating different biomarkers and combining them with the joint and BMD results to provide a systematic approach for elucidating the treatment outcomes of PwHA treated with rFVIIIFc is major goal of this study.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's planned enrollment of 45 is below the median of 81 across 310 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Tri-Service General Hospital is the lead sponsor of 108 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
severe hemophilia A patients or moderate hemophilia A patients with hemophilic arthropathy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Haemophilia Early Arthropathy Detection :HEAD-US, HJHS, and DEXA scan 2. serum markers : CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN) 3. Quality of life assessments (Haem-A-QoL, EQ-5D)
Diagnostic Test: serum biomarker.
serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)
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
Serum markers
CTX-II, COMP, HSCRP, TNF-ALPHA, CTX-I, SRANKL, OPG, OPN
Time frame: up to 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Dec 2027, 53 months after the start.
Of 78 non-industry observational studies under Hemophilia A, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 96. This study's planned 53 months is above that.
Counting every sponsor, half of 131 studies reached it within 45 months; a quarter within 25 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
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