Evaluating the effects of a treatment on bone health in patients with severe hemophilia A
Official title: 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)
Run by Tri-Service General Hospital (TSGH) · NCT05981274 · Data updated 2026-11-12
This study is testing how a new treatment for severe hemophilia A affects bone and joint health over time to help make monitoring easier for patients.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Men only |
| Enrollment | 45 (estimated) |
| Sponsor | Tri-Service General Hospital (TSGH) Academic / other |
| Locations | 1 site (Taipei, Neihu Dist.) |
| Status | Recruiting |
| Started | July 14, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 10, 2024 |
| Trial ID | NCT05981274 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients of all ages with severe hemophilia A or moderate hemophilia A with hemophilic arthropathy who are currently on rFVIIIFc prophylaxis.
✕Probably not a fit
Patients with current inhibitors or those with significant neurological or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to systematically evaluate the treatment outcomes related to joint and bone health in patients with severe hemophilia A who are receiving recombinant Factor VIII Fc (rFVIIIFc) prophylaxis. It will compare clinical outcomes from one year before and after switching to extended half-life (EHL) therapy and explore potential biomarkers that could simplify the assessment of joint and bone health. The study seeks to provide a more convenient and efficient method for monitoring these health aspects, which are currently time-consuming and costly to evaluate. By identifying biomarkers, the study hopes to enhance clinical practice for individuals with hemophilia A.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of joint and bone health in patients with hemophilia A.
How similar studies have gone: Other studies have shown promise in evaluating treatment outcomes in hemophilia patients, but the specific approach of using biomarkers for joint and bone health assessment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Tri-Service General Hospital Hemophilia Care Center
Taipei, Neihu Dist., Taiwan Recruiting
Study contacts
- Study coordinator: Yeu-Chin Chen
- Email: yeuchin99@gmail.com
- Phone: (+886)2-87923311
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Understanding antibody changes in hemophilia A patients treated with emicizumab
This study looks at how the immune system reacts to emicizumab treatment in people with severe hemophilia A by checking leftover samples from their regular doctor visits.
-
Looking at chronic pain in adults with severe haemophilia A
This project will see if chronic pain in adults with severe haemophilia A who have been on bispecific monoclonal antibodies is linked to pain catastrophising, confidence in managing pain, and body image.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.