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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Goethe University Academic / other |
| Drugs / interventions | emicizumab |
| Locations | 1 site (Frankfurt am Main, Hesse) |
| Status | Recruiting |
| Started | April 26, 2023 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | July 10, 2023 |
| Trial ID | NCT05802836 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
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University Hospital Frankfurt, Goethe University
Frankfurt am Main, Hesse, Germany Recruiting
Study contacts
- Principal investigator: Christoph Koenigs, PD Dr. Dr — Goethe University
- Study coordinator: Stephan Schultze-Strasser, Dr.
- Email: stephan.schultze-strasser@kgu.de
- Phone: +496963016998
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Switching from Emicizumab to Marstacimab in Severe Hemophilia A
This study is testing if switching from emicizumab to marstacimab is safe and how well the body handles the new medication in people with severe hemophilia A.
-
Using Nuwiq to manage bleeding in hemophilia A patients during major surgery
This study is testing if Nuwiq can help prevent bleeding during major surgery for boys and men over 12 with severe hemophilia A who are already using another treatment called emicizumab.
-
NXT007 versus emicizumab to prevent bleeds in people with Hemophilia A
This will test whether NXT007 prevents bleeding better than emicizumab in people aged 12 and older with Hemophilia A, including those with or without factor VIII inhibitors.
-
Emicizumab prophylaxis for people with Type 3 von Willebrand disease
This trial will test whether regular emicizumab injections reduce bleeds compared with on-demand standard therapy for people aged 1 month and older with Type 3 von Willebrand disease, while also studying people already on prophylaxis using their prior data.
-
Testing fitusiran to prevent bleeds in severe hemophilia A patients switching from emicizumab
This study is testing if fitusiran can help prevent bleeding in men with severe hemophilia A who are switching from another treatment called emicizumab.
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Evaluating the effects of a treatment on bone health in patients with severe hemophilia A
This study is testing how a new treatment for severe hemophilia A affects bone and joint health over time to help make monitoring easier for patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.