By InvitationNot Applicable

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

Thailand19 participantsStarted 2024-04-01

Plain-language summary

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.

Who can participate

SexALL

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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.

What they're measuring

The effectiveness of standard low dose FVIII concentrate prophylaxis and PK-guided eHL FVIII prophylaxis

Timeframe: 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

Timeframe: From enrollment to the end of treatment at 32 weeks

Trial details

NCT IDNCT06816953

SponsorChulalongkorn University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Hemophilia A trials