Podgorica

Researchers are evaluating the effectiveness and safety of an intravenous human plasma-derived C1 esterase inhibitor (C1-INH) concentrate in people with congenital C1-INH deficiency. The study focuses on treating and preventing acute hereditary angioedema attacks before procedures and is designed as a phase 3, randomized, double-blind, placebo-controlled trial conducted across multiple centers. Participants will receive either OCTA-C1-INH, a purified concentrate of human C1-INH given as a slow intravenous injection at a dose of 20 IU per kg of body weight, or a placebo of sodium chloride injection. The treatment is administered after reconstitution in water for injection. The study includes different phases, including treatment of acute attacks and prevention before procedures. During the study, participants will be monitored for the time it takes to experience clear symptom relief within four hours after injection. Researchers will evaluate safety and efficacy through clinical assessments and laboratory tests. Participants must comply with study procedures and attend visits as scheduled. The total duration and follow-up details are organized to ensure thorough evaluation of treatment effects and safety.