Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:05 AM
Study NCT ID:
NCT07326592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000515', 'term': 'alpha 1-Antitrypsin'}, {'id': 'C000654178', 'term': 'Respreeza'}], 'ancestors': [{'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015843', 'term': 'Serpins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000209', 'term': 'Acute-Phase Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000510', 'term': 'Alpha-Globulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor will also be blinded to treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a double blind, parallel group assignment study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2033-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual rate of change in adjusted lung density', 'timeFrame': 'From Baseline to Month 36', 'description': 'The annual rate of change (expressed as gram per liter per year \\[g/L/year\\]) in adjusted lung density (15th percentile lung density \\[PD15\\]) will be calculated on CT scan assessments of whole lung at total lung capacity (TLC).'}], 'secondaryOutcomes': [{'measure': 'Annual rate of change in forced expiratory volume in 1 second percent predicted (FEV1%)', 'timeFrame': 'From Baseline to Month 36', 'description': 'The annual rate of change in FEV1% will be assessed by spirometry.'}, {'measure': 'Annual rate of change in diffusion capacity of carbon monoxide (DLco)', 'timeFrame': 'From Baseline to Month 36', 'description': 'The annual rate of change in DLco will be assessed by gas transfer using site machinery.'}, {'measure': 'Number of severe pulmonary exacerbations', 'timeFrame': 'From screening up to Month 36', 'description': "Pulmonary excerbations will be assessed by the investigator using Rodriguez-Roisin criteria, where an exacerbation is defined as: a sustained worsening of the patient's condition, from a stable state and beyond normal day-to-day variations, necessitating a change in regular medication in a patient with underlying chronic obstructive pulmonary disease (COPD). A severe exacerbation is defined as an event requiring the introduction of corticosteroids and / or antibiotics which results in hospitalization or death."}, {'measure': 'Duration of severe pulmonary exacerbations', 'timeFrame': 'From screening up to Month 36', 'description': "Pulmonary excerbations will be assessed by the investigator using Rodriguez-Roisin criteria, where an exacerbation is defined as: a sustained worsening of the patient's condition, from a stable state and beyond normal day-to-day variations, necessitating a change in regular medication in a patient with underlying COPD. A severe exacerbation is defined as an event requiring the introduction of corticosteroids and / or antibiotics which results in hospitalization or death."}, {'measure': 'Number of participants experiencing treatment emergent adverse events (TEAEs)', 'timeFrame': 'From screening up to Month 36'}, {'measure': 'Percentage of participants experiencing TEAEs', 'timeFrame': 'From screening up to Month 36'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Progressive Emphysema', 'Chronic Pulmonary Disease'], 'conditions': ['Alpha1 Antitrypsin Deficiency', 'Alpha1-Proteinase Inhibitor Deficiency', 'Emphysema']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age greater than or equal to (\\>=) 18 and less than or equal to (\\<=) 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/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).\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.'}, 'identificationModule': {'nctId': 'NCT07326592', 'briefTitle': '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CE1226_4003'}, 'secondaryIdInfos': [{'id': '2025-522964-33-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CE1226 low dose', 'description': 'CE1226 at low dose.', 'interventionNames': ['Biological: CE1226']}, {'type': 'EXPERIMENTAL', 'label': 'CE1226 medium dose', 'description': 'CE1226 at medium dose.', 'interventionNames': ['Biological: CE1226']}, {'type': 'EXPERIMENTAL', 'label': 'CE1226 high dose', 'description': 'CE1226 at high dose.', 'interventionNames': ['Biological: CE1226']}], 'interventions': [{'name': 'CE1226', 'type': 'BIOLOGICAL', 'otherNames': ['Human alpha1-proteinase inhibitor', 'Respreeza', 'Zemaira'], 'description': 'CE1226 will be administered via intravenous (IV) infusion weekly over 3 years.', 'armGroupLabels': ['CE1226 high dose', 'CE1226 low dose', 'CE1226 medium dose']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Trial Registration Coordinator', 'role': 'CONTACT', 'email': 'clinicaltrials@cslbehring.com', 'phone': '+1 610-878-4697'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Requests for IPD will generally be considered once review by major regulatory authorities (i.e. FDA, EMA) is complete and the primary publication is available.', 'ipdSharing': 'YES', 'description': 'CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.', 'accessCriteria': 'Proposed research should seek to answer a previously unanswered important medical or scientific question.\n\nApplicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.\n\nIf the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}