Status:
RECRUITING
Comparison of Outcomes Between Low Dose Emicizumab and Factor VIII in Clinically Severe Hemophilia A
Lead Sponsor:
Chulalongkorn University
Conditions:
Severe Hemophilia A Without Inhibitor
Joint Bleed
Eligibility:
MALE
3-30 years
Phase:
PHASE2
PHASE3
Brief Summary
* To outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration * To study pharmacokinetic, side effect of low dose Emicizumab
Detailed Description
* To compare outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration using ABR, AJBR and HJHS, HaemoQoL * To study pharmacokinetic, side effect and effectiveness of low d...
Eligibility Criteria
Inclusion
- Severe or moderate Hemophilia A with baseline FVIII:C of \<3 IU/dl or severe bleeding phenotype
- Receiving low dose FVIII prophylaxis for at least 6 months
Exclusion
- Detectable FVIII inhibitor at screening
- Detectable FVIII inhibitor at screening Having other underlying diseases: Juvenile rheumatoid arthritis, metabolic bone diseases, or other conditions mimicking or causing joint diseases
Key Trial Info
Start Date :
June 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 21 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06155955
Start Date
June 22 2023
End Date
June 21 2024
Last Update
March 5 2024
Active Locations (1)
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1
King Chulalongkorn Memorial hospital
Bangkok, Thailand, 10330