RecruitingNot Applicable

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

Germany100 participantsStarted 2023-04-26

Plain-language summary

The goal of this observational study is to learn about the changes of antibodies and inhibitors against the coagulation factor VIII in patients with severe hemophilia A receiving emicizumab therapy. No additional visits or procedures are planned. Patients in this study will continue to receive their routine care and analysis will be done from left over samples from routine visits.

Who can participate

SexALL

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 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

What they're measuring

FVIII inhibitor development in inhibitor negative subjects

Timeframe: 3 years

FVIII antibody development in inhibitor negative subjects

Timeframe: 3 years

FVIII inhibitor disappearance in inhibitor positive subjects

Timeframe: 3 years

FVIII antibody disappearance in inhibitor positive subjects

Timeframe: 3 years

Trial details

NCT IDNCT05802836

SponsorChristoph Königs

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12

Contact for this trial

Stephan Schultze-Strasser, Dr.

+496963016998 stephan.schultze-strasser@kgu.de

View on ClinicalTrials.gov More Severe Hemophilia A trials