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Enrolling by Invitation

NCT Number: NCT06816953

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Department, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital

Bangkok, Patumwan, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HEAD-US

Diagnostic Test

HEAD-US for evaluate haemophilic arthropathy in 6 joints. (Elbow, Knee, Ankle)

Urinary carboxy-terminal cross linked telopeptide of type II collagen

Diagnostic Test

Cartilage biomarker represent cartilage degradation

inflammatory markers

Diagnostic Test

Inflammatory markers included CBC, Ferritin, ESR, CRP

Primary outcomes

  1. 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

    To compare the effectiveness of standard weight base FVIII concentrate prophylaxis and pharmacokinetic guided extended half life FVIII prophylaxis in managing hemophilic arthropathy using cartilage biomarkers.

  2. 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

    To compare the effectiveness of standard weight base FVIII concentrate prophylaxis and pharmacokinetic guided extended half life FVIII prophylaxis in managing hemophilic arthropathy using HEAD-US score.

Secondary outcomes

  1. Correlation between cartilage biomarkers and Inflammatory markers

    Time frame: From enrollment to the end of treatment at 32 weeks

    To investigate the correlation between cartilage biomarkers (Urine CTX-II), Inflammatory markers (CBC, Ferritin, ESR, CRP) and ultrasound (HEAD-US score) comparing standard weight base low dose prophylaxis with pharmacokinetic guided extended half life FVIII concentrates

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Acronym: HEADUS_SHA8

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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