Understanding antibody changes in hemophilia A patients treated with emicizumab
Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Goethe University Academic / other |
| Drugs / interventions | emicizumab |
| Locations | 1 site (Frankfurt am Main, Hesse) |
| Trial ID | NCT05802836 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with severe congenital hemophilia A who are currently being treated with emicizumab.
Not a fit: Patients who are not receiving emicizumab or those undergoing immunosuppressive therapy may not benefit from this study.
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 performed: While this approach is observational and builds on existing knowledge, similar studies have successfully provided insights into antibody dynamics in other treatment contexts.
Eligibility criteria
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 this trial is running
Frankfurt am Main, Hesse
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.