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 range

3 Years – 30 Years

Sex

MALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

3 Years – 30 Years

Sex

MALE

See this in plain English?

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

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