Alpha1 Antitrypsin Deficiency

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)

NCT07326592 | PHASE 4 | INTERVENTIONAL

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).

0 Sites

270 Participants

NOT YET RECRUITING

18 Years to 65 Years

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Study Eligibility Criteria

Inclusion Criteria

* • Age greater than or equal to (\>=) 18 and less than or equal to (\<=) 65 years at the time of providing written informed consent.
* • Confirmed diagnosis of emphysema related to AATD with either the PiZZ, PiZ(null), or Pi(null/null) genotype with documented serum AAT levels less than (\<) 11 micrometer (μM) (or \< 50 mg/dL \[milligram/deciliter\]) at any time before the first administration of CE1226 on Day 1 (Baseline).

Exclusion Criteria

* • Participants should not have acute illness or pulmonary exacerbation within 6 weeks before the first administration of CE1226 on Day 1 (Baseline).
* • Participants should not have previously received gene therapy for AATD at any point.
* • Participants with liver disease secondary to AATD.

Additional Studies

Additional studies can be found at ClinicalTrials.gov