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Enrolling by invitation NCT06816953

Cartilage Biomarkers and HEAD-US Score in Severe Hemophilia A Patients Receiving FVIII Prophylaxis

No phase Interventional Hemophilia A

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HEAD-US, Urinary carboxy-terminal cross linked telopeptide of type II collagen, Inflammatory markers.
Who it may be relevant to
Registry conditions: Hemophilia A. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cartilage Biomarkers and HEAD-US Score in Severe Hemophilia A Patients Receiving Low Dose FVIII Prophylaxis

Overview

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.

Interventions

  • Diagnostic test HEAD-US
    HEAD-US for evaluate haemophilic arthropathy in 6 joints. (Elbow, Knee, Ankle)
  • Diagnostic test Urinary carboxy-terminal cross linked telopeptide of type II collagen
    Cartilage biomarker represent cartilage degradation
  • Diagnostic test Inflammatory markers
    Inflammatory markers included CBC, Ferritin, ESR, CRP

Primary outcome measures

  • The effectiveness of standard low dose FVIII concentrate prophylaxis and PK-guided eHL FVIII prophylaxis [Time frame: From enrollment to the end of treatment at 32 weeks]
  • The effectiveness of standard low dose FVIII concentrate prophylaxis and PK-guided eHL FVIII prophylaxis [Time frame: From enrollment to the end of treatment at 32 weeks]
Secondary outcome measures (1)
  • Correlation between cartilage biomarkers and Inflammatory markers [Time frame: From enrollment to the end of treatment at 32 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • patients with underlying condition affecting the joints such as osteoarthritis, metabolic bone disease, etc.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Pediatric Department, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn — Bangkok

Identifiers

NCT: NCT06816953 · 0736/67 · Ratchadapisek Research Fund

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗