Plasma-derived C1 esterase inhibitor pharmacokinetics and safety in patients with hereditary angioedema.

ABSTRACT:

Background

Over 40 years of use demonstrates that complement 1 esterase inhibitor (C1-INH) concentrate is effective and well tolerated for acute edema attacks and prophylaxis in patients with hereditary angioedema. OCTA-C1-INH is a new stable, virus-inactivated, nanofiltrated concentrate of C1-INH derived from human plasma.

Objective

We investigated the pharmacokinetics and safety profile of new C1-INH in people with hereditary angioedema during an attack-free period.

Methods

In this prospective, multicenter, open-label, single-arm study, adults with hereditary angioedema type I/II received a single intravenous dose of 20 IU/kg C1-INH. Blood samples were taken ≤30 minutes before infusion, and 0, 0.25, 1, 2, 6, 12, 24, 48, 72, 120, 144, and 168 hours after infusion. Th

SUBMITTER: Martinez-Saguer I 

PROVIDER: S-EPMC10684372 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature