clinical trial · NCT07326592
Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)
CSL Behring·phase4·not yet recruiting·n = 270
Alpha1 Antitrypsin DeficiencyAlpha1-Proteinase Inhibitor DeficiencyEmphysemaCE1226
brief summary
This is a multicenter, parallel-group, double-blind, randomized phase 4 study designed to identify the optimal dose of CE1226 (2 active doses) to slow disease progression as assessed by reduced rates of annual lung density decline in alpha-1 antitrypsin (AAT) deficient participants over 3 years as compared with the marketed dose 60 milligrams per kilogram (mg/kg).
started
Apr 15, 2026
primary completion
Sep 15, 2033
completion
Sep 15, 2033
last updated
Mar 6, 2026
official title
A Phase 4, Multicenter, Double-blind, Study to Investigate the Efficacy, Safety, and Tolerability of 3 Active Doses of Respreeza® / Zemaira® Weekly Intravenous Infusions Administered Over 3 Years as Longterm Maintenance Therapy in Adult Subjects With Emphysema Related to Alpha1 Antitrypsin Deficiency
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol