Phase III trial of SC version of Berinert begins for HAE - CSL Behring

CSL Behring has announced it has enrolled the first patient in COMPACT, an international Phase III study of a volume-reduced, subcutaneous formulation of Berinert (C1-esterase inhibitor concentrate) in patients with frequent Hereditary Angioedema (HAE) attacks. This phase of the COMPACT program will assess the efficacy and safety of a new formulation of the CSL Behring C1-INH concentrate in preventing hereditary angioedema attacks when the therapy is administered twice weekly under the skin (i.e., subcutaneously) of patients diagnosed with HAE.

The COMPACT phase III, double-blind, randomized, placebo-controlled, cross-over study enrolls adolescent and adult patients with HAE types I or II who have frequent attacks. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment. Subjects will be able to take on-demand medication for acute attacks at any time during the study.