An interventional study of HEAD-US and Urinary carboxy-terminal cross linked telopeptide of type II collagen in Hemophilia A, sponsored by Chulalongkorn University. Enrolling by invitation at 1 site in Thailand. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's planned enrollment of 19 is below the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Standard weight based low dose FVIII concentrates prophylaxis
Diagnostic Test: HEAD-US · Diagnostic Test: Urinary carboxy-terminal cross linked telopeptide of type II collagen · Diagnostic Test: Inflammatory markers
Pharmacokinetic guided extended half life FVIII prophylaxis
Diagnostic Test: HEAD-US · Diagnostic Test: Urinary carboxy-terminal cross linked telopeptide of type II collagen · Diagnostic Test: Inflammatory markers
HEAD-US for evaluate haemophilic arthropathy in 6 joints. (Elbow, Knee, Ankle)
Cartilage biomarker represent cartilage degradation
Inflammatory markers included CBC, Ferritin, ESR, CRP
The effectiveness of standard low dose FVIII concentrate prophylaxis and PK-guided eHL FVIII prophylaxis
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.
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
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.
Time frame: From enrollment to the end of treatment at 32 weeks
Correlation between cartilage biomarkers and Inflammatory markers
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
Time frame: From enrollment to the end of treatment at 32 weeks
Plan to share: Yes
Supporting information: Study protocol
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Chulalongkorn University