Standard versus tailored FVIII dosing and joint health in severe hemophilia A
Compares standard and tailored FVIII dosing in severe hemophilia A.
Key facts
- Who runs it
- Chulalongkorn University
- Where
- Bangkok, ThailandSee the site
- Trial code
- Registry title
- Cartilage Biomarkers and HEAD-US Score in Severe Hemophilia A Patients Receiving FVIII Prophylaxis
- Status
- Enrolling by invitation
- People taking part
- 19 people, planned
- Started
- 1 Apr 2024
- Planned end
- 28 Feb 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- HEAD-US
- Urinary carboxy-terminal cross linked telopeptide of type II collagen
- Inflammatory markers
- Record updated
- 10 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with severe hemophilia A who have had regular low dose FVIII prophylaxis and have no FVIII inhibitor.
- Sex
- All sexes can join.
- Disease stage
- Severe hemophilia A.
- Earlier treatment
- Standard low dose FVIII prophylaxis 1-3 times per week for at least 6 months before joining.
- Biomarker or test result
- No history of FVIII inhibitor (<0.6 Bethesda unit/ml).
Main reasons for not taking part
- Another condition affecting the joints, such as osteoarthritis or metabolic bone disease
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- patients with severe hemophilia A
- previously receiving standard low dose FVIII prophylaxis 1-3 times per week for at least 6 months prior to enrollment in the project
- no history of FVIII inhibitor (<0.6 Bethesda unit/ml)
- obtained consent from both patients and their parents
Who cannot take part
- patients with underlying condition affecting the joints such as osteoarthritis, metabolic bone disease, etc
Where in Thailand
- Pediatric Department, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalBangkok, ThailandNo longer taking part
About the trial
What the trial wants to find out
Patients with severe hemophilia A often develop joint complication requiring careful monitoring. This study aimed to compare the effectiveness of standard low dose weight-based FVIII concentrates (CFCs) prophylaxis with pharmacokinetic-guided extended half-life FVIII concentrates (eHLFVIII) using cartilage biomarkers and HEAD-US score.
The 2 groups in the trial
- Standard low dose FVIII prophylaxisTreatment being tested
Standard weight based low dose FVIII concentrates prophylaxis
Treatment: HEAD-US, Urinary carboxy-terminal cross linked telopeptide of type II collagen, and Inflammatory markers
- PK guided Extended half life FVIII prophylaxisExisting treatment, for comparison
Pharmacokinetic guided extended half life FVIII prophylaxis
Treatment: HEAD-US, Urinary carboxy-terminal cross linked telopeptide of type II collagen, and Inflammatory markers
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cartilage Biomarkers and HEAD-US Score in Severe Hemophilia A Patients Receiving Low Dose FVIII Prophylaxis
- Plain-language title
- Standard versus tailored FVIII dosing and joint health in severe hemophilia AGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 February 2025