Status: Not yet recruiting
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)
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).
Participants needed: 270
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: CSL BehringUpdated: May 15, 2026
Eligibility criteria
• Age greater than or equal to (>=) 18 and less than or equal to (<=) 65 years a... [+1]
• Participants should not have acute illness or pulmonary exacerbation within 6... [+2]