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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)

RecruitingPhase 4Ages 18 Years - 65 YearsAllCSL Behring
NCT07326592 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • CE1226
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Where

2 sites
Aalborg Universitetshospital, Syd
Aalborg, Denmark
Sygehus Lillebælt, Vejle
Vejle, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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