drugset / Trial / NCT06361537

Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks

NCT06361537 ↗

Phase 3 Recruiting 124 enrolled Octapharma
RandomizedParallel-groupDouble-blindTreatment

Summary

Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks

Timeline

Start
2024-04-30
Primary completion
2026-12
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject OCTA-C1-INH Protein / enzyme biologic 20 iu/kg Intravenous

Indications