Status:
COMPLETED
Clinical Outcomes of Low Dose PK-guided EHL FVIII Concentrates Versus Standard Prophylaxis in Severe Haemophilia A
Lead Sponsor:
Chulalongkorn University
Conditions:
Severe Hemophilia A Without Inhibitor
Eligibility:
MALE
5-25 years
Phase:
PHASE4
Brief Summary
Individualised pharmacokinetic (PK)-guided dosing of extended half-life (EHL) FVIII concentrates prophylaxis may reduce hemophilia A bleeding events than previous prophylactic regimen. Methods A sing...
Detailed Description
Clinical Outcomes of Low Dose Pharmacokinetic-guided Extended Half-life Versus Low Dose Standard Half-life FVIII Concentrates Prophylaxis in Thai Severe Haemophilia A Patients Haemophilia A (HA) is a...
Eligibility Criteria
Inclusion
- severe or moderate with clinically HA with a baseline FVIII level of ≤3 IU/dL
- age 5-25 years
- \> 50 exposure days (EDs) without inhibitor
- close proximity to the comprehensive care center at KCMH
- compliant to treatment
- use of the pre-study prophylaxis regimen for ≥ 1 year prior to enrolment in the study.
Exclusion
- history of FVIII inhibitor (titer \> 0.6 Bethesda units \[BU\]) and detectable FVIII inhibitor at screening (titer \> 0.6 BU)
- planned major surgery, and (3) concomitant serious conditions including symptomatic human immunodeficiency virus (HIV) infection, juvenile rheumatoid arthritis, metabolic bone disease, or other conditions known to mimic or cause joint diseases.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05281185
Start Date
July 1 2021
End Date
April 30 2022
Last Update
July 20 2022
Active Locations (1)
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1
Pediatric department, Faculty of medicine, Chulalongkorn University
Pathum Wan, Bangkok, Thailand, 10330