drugset / Trial / NCT06690047

Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest)

NCT06690047 ↗

Phase 4 Completed 5 enrolled Bernstein Clinical Research Center
RandomizedCrossoverOpen-labelPrevention

Summary

To assess the efficacy of recombinant human C1-esterase inhibitor in the management of HAE prodrome for preventing the progression from prodrome to an acute angioedema attacks. Subjects will either receive Ruconest after the first 2 prodromes or during the last 2 prodromes. 5 clinic visits will occur within 24 hours of a prodrome. Subjects will complete prodrome severity and angioedema attack diaries

Timeline

Start
2018-08-14
Primary completion
2022-04-28
Completion
2022-04-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator recombinant human C1 inhibitor Protein / enzyme biologic 50 iu/kg Intravenous

Indications