UnknownPhase 2/3

Comparison of Outcomes Between Low Dose Emicizumab and Factor VIII in Clinically Severe Hemophilia A

Thailand15 participantsStarted 2023-06-22

Plain-language summary

* To outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration * To study pharmacokinetic, side effect of low dose Emicizumab

Who can participate

Age range3 Years – 30 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

spontaneous and traumatic bleeding rate

Timeframe: 6 months after start low dose emicizumab as secondary prophylaxis treatment

treated spontaneous bleeds, treated joint bleeds

Timeframe: 6 months after start low dose emicizumab as secondary prophylaxis treatment

The function of the knee, elbow, and ankle joints

Timeframe: 6 months after start low dose emicizumab as secondary prophylaxis treatment

Trial details

NCT IDNCT06155955

SponsorChulalongkorn University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-21

Contact for this trial

NUCHANUN KESSAKORN, MD

662-5054639 nuchanun.ks@gmail.com

View on ClinicalTrials.gov More Severe Hemophilia A Without Inhibitor trials