Evaluating the effects of a treatment on bone health in patients with severe hemophilia A
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)
Tri-Service General Hospital · NCT05981274
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 |
|---|---|
| Enrollment | 45 (estimated) |
| Sex | Male |
| Sponsor | Tri-Service General Hospital (other) |
| Locations | 1 site (Taipei, Neihu Dist.) |
| Trial ID | NCT05981274 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with current inhibitors or those with significant neurological or psychiatric conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Taipei, Neihu Dist.
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Severe Hemophilia A Without Inhibitor