eligibility_summary
Inclusion: diagnosed with acquired hemophilia A (AHA), women postmenopausal or using strict contraception, good compliance. Exclusion: congenital hemophilia with inhibitor, pregnancy/lactation, positive HBV/HCV/HIV/syphilis tests, poor compliance or inability to use contraception, investigator deems unsuitable, immunosuppression within 4 weeks with inhibitor decreasing <50%, acquired von Willebrand disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05849740 (multicenter, single-arm, Phase 4) tests daratumumab plus corticosteroids for acquired hemophilia A. Daratumumab is an anti-CD38 IgG1 monoclonal antibody that binds CD38 on plasmablasts/plasma cells and depletes them via ADCC, CDC, ADCP and apoptosis, aiming to eliminate production of factor VIII–neutralizing autoantibodies. Corticosteroids (systemic glucocorticoids) are broad immunosuppressants that reduce lymphocyte activation and proinflammatory cytokine transcription via glucocorticoid receptor signaling, further suppressing autoantibody generation. Targets: CD38+ antibody-secreting plasma cells, B-cell/autoantibody pathways, downstream effect is reduction of FVIII inhibitors to restore the intrinsic coagulation pathway.