Clinical trial Recruiting at 1 site Observational

Understanding antibody changes in hemophilia A patients treated with emicizumab

Official title: Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab

Run by Goethe University · NCT05802836 · Data updated 2026-11-12

This study looks at how the immune system reacts to emicizumab treatment in people with severe hemophilia A by checking leftover samples from their regular doctor visits.

More Severe Hemophilia A trials

Quick facts

Study typeObservational
SexAll
Enrollment100 (estimated)
SponsorGoethe University
Academic / other
Drugs / interventionsemicizumab
Locations1 site (Frankfurt am Main, Hesse)
StatusRecruiting
StartedApril 26, 2023
Main results expectedDecember 2028
Study endsDecember 2029
Registry record updatedJuly 10, 2023
Trial IDNCT05802836 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with severe congenital hemophilia A who are currently being treated with emicizumab.

Probably not a fit

Patients who are not receiving emicizumab or those undergoing immunosuppressive therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the dynamics of antibodies and inhibitors against coagulation factor VIII in patients with severe hemophilia A who are receiving emicizumab therapy. The study will analyze leftover samples from routine care visits, allowing researchers to monitor changes without requiring additional procedures or visits from participants. By focusing on patients already undergoing treatment, the study seeks to provide insights into the immune response associated with emicizumab.

Why it matters

Potential benefit: If successful, this study could enhance understanding of immune responses in hemophilia A patients, potentially leading to improved treatment strategies.

How similar studies have gone: While this approach is observational and builds on existing knowledge, similar studies have successfully provided insights into antibody dynamics in other treatment contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Severe congenital hemophilia A (CHA)
* Treatment with emicizumab irrespective of any other treatment
* Informed consent

Exclusion Criteria:

* No therapy with emicizumab
* Immunosuppressive therapy
* HIV-infection with CD4 (cluster of differentiation 4) cells \<200/µl

Where it's running

  • University Hospital Frankfurt, Goethe University
    Frankfurt am Main, Hesse, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.