[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618051":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":44,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":42,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":42,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":70,"whyStopped":42,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":42},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"CE1226 low dose","ACTIVE_COMPARATOR","CE1226 at low dose.",[13],"Biological: CE1226",{"label":15,"type":16,"description":17,"interventionNames":18},"CE1226 medium dose","EXPERIMENTAL","CE1226 at medium dose.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"CE1226 high dose","CE1226 at high dose.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","CE1226","CE1226 will be administered via intravenous (IV) infusion weekly over 3 years.",[20,9,15],[30,31,32],"Human alpha1-proteinase inhibitor","Respreeza","Zemaira",[34],{"name":35,"affiliation":5,"role":36},"Study Director","STUDY_DIRECTOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Trial Registration Coordinator","CONTACT","+1 610-878-4697",null,"clinicaltrials@cslbehring.com",{"type":45,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100618051","phase-4-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-100618051",false,"NCT07326592","Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza \u002F Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)","A Phase 4, Multicenter, Double-blind, Study to Investigate the Efficacy, Safety, and Tolerability of 3 Active Doses of Respreeza® \u002F Zemaira® Weekly Intravenous Infusions Administered Over 3 Years as Longterm Maintenance Therapy in Adult Subjects With Emphysema Related to Alpha1 Antitrypsin Deficiency","Inclusion Criteria:\n\n* • Age greater than or equal to (\\>=) 18 and less than or equal to (\\\u003C=) 65 years at the time of providing written informed consent.\n* • Confirmed diagnosis of emphysema related to AATD with either the PiZZ, PiZ(null), or Pi(null\u002Fnull) genotype with documented serum AAT levels less than (\\\u003C) 11 micrometer (μM) (or \\\u003C 50 mg\u002FdL \\[milligram\u002Fdeciliter\\]) at any time before the first administration of CE1226 on Day 1 (Baseline).\n\nExclusion Criteria:\n\n* • Participants should not have acute illness or pulmonary exacerbation within 6 weeks before the first administration of CE1226 on Day 1 (Baseline).\n* • Participants should not have previously received gene therapy for AATD at any point.\n* • Participants with liver disease secondary to AATD.","ALL","18 Years","65 Years",{"count":57,"type":58},270,"ESTIMATED","INTERVENTIONAL",[61],"PHASE4","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\u002Fkg).",[64,65,66],"Alpha1 Antitrypsin Deficiency","Alpha1-Proteinase Inhibitor Deficiency","Emphysema",[68,69],"Progressive Emphysema","Chronic Pulmonary Disease","NOT_YET_RECRUITING","2026-05-14",{"date":73,"type":74},"2026-05-15","ACTUAL",{"date":76,"type":58},"2026-07-20",{"date":78,"type":58},"2033-09-15",{"name":5,"class":6}]