Clinical Trial

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

Recruiting Phase 3
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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
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2024-04-05; most recent amendment 2026-07-16.
Status change: Not Yet Recruiting → Recruiting 2024-05-02
Trial Details
NCT Number NCT06361537
Lead Sponsor Octapharma
Conditions Acute Hereditary Angio Edema
Enrollment 124 participants
Start Date 2024-04-30
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-06