Blood test may predict bleeding risk in hemophilia a patients on emicizumab
NCT ID NCT04472169
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether measuring the amount of emicizumab in the blood can help predict bleeding risk in people with severe hemophilia A. Researchers will follow 100 adults and children who are already taking emicizumab and track any bleeding events over about a year. The goal is to see if drug levels measured by a special lab test can identify who is at higher risk for bleeds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- emicizumab
- What this could lead to
- If successful, this could lead to a blood test that helps doctors adjust emicizumab dosing to better prevent bleeding in people with severe hemophilia A.
- What could go wrong
- This is an observational study, not a treatment trial. It may find no clear link between drug levels and bleeding risk, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
100 patients with severe hemophilia A will be included in the study on 2 french Hemophilia Treatement Centers (CHU Lille and CHU Caen)
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult or child with Clinical diagnosis of severe hemophilia A (FVIII activity \< 1%) with or without inhibitor * Clinical indication to emicizumab therapy Exclusion Criteria: * Refusal to give informed consent * acquired hemophilia A * other inherited or acquired bleeding disorder * bodyweight \< 10 kgs
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU de Caen
Caen, France
-
Institut Coeur-Poumon, Pôle d'Hématologie-Transfusion, CHU
Lille, 59037, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Multicenter study to evaluate the efficacy, safety, immunogenicity, and pharmacokinetics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia a (Adults and adolescents)
- Can a newer clotting factor keep its effectiveness in hemophilia a?
- Can a new injection tame hemophilia a bleeding?
- A Once-a-Week shot could transform hemophilia Care—Even for those with inhibitors
- Can a new clotting factor offer better bleed protection for severe hemophilia?
- Do newer hemophilia drugs protect joints better? study aims to find out