NCT05981274Recruiting
A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype 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)
Source: ClinicalTrials.gov · Last updated 10 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 45 (estimated)
- First submitted
- 17 Jul 2023
- Start date
- 14 Jul 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Diseases
- Haemophilia
- NCT number
- NCT05981274
What you commit to
- Study type: Observational
- Planned participants: 45
- From 14 Jul 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with current inhibitors.
Other illness
- History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
- History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
Other
- Participants of other interventional studies.
- Significantly impaired vision/hearing
Who the study is looking for
- 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
Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tri-Service General Hospital Hemophilia Care Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.