Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01499420
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2011-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584257', 'term': 'CSL112'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'dispFirstSubmitDate': '2014-01-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-08', 'studyFirstSubmitDate': '2011-12-19', 'dispFirstSubmitQcDate': '2014-01-08', 'studyFirstSubmitQcDate': '2011-12-22', 'dispFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '14 days', 'description': 'The frequency of study product-related adverse events'}, {'measure': 'Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)', 'timeFrame': '14 days', 'description': 'Number of subjects with clinically significant elevation of ALT or AST'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile of apolipoprotein A-I (apoA-I)', 'timeFrame': '9 days', 'description': 'Plasma apoA-I concentration with and without baseline correction'}, {'measure': 'Plasma apoA-I area under the curve (AUC)', 'timeFrame': '9 days'}, {'measure': 'Plasma apoA-I Cmax', 'timeFrame': '9 days'}, {'measure': 'Plasma apoA-I Tmax', 'timeFrame': '9 days'}]}, 'conditionsModule': {'conditions': ['Stable Atherothrombotic Disease']}, 'referencesModule': {'references': [{'pmid': '33217027', 'type': 'DERIVED', 'citation': 'Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.'}, {'pmid': '26307570', 'type': 'DERIVED', 'citation': "Tricoci P, D'Andrea DM, Gurbel PA, Yao Z, Cuchel M, Winston B, Schott R, Weiss R, Blazing MA, Cannon L, Bailey A, Angiolillo DJ, Gille A, Shear CL, Wright SD, Alexander JH. Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial. J Am Heart Assoc. 2015 Aug 25;4(8):e002171. doi: 10.1161/JAHA.115.002171."}]}, 'descriptionModule': {'briefSummary': 'Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 years to 80 years.\n* Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization.\n* Subjects on a stable medication regimen.\n* Body weight 50 kg or greater at screening.\n\nExclusion Criteria:\n\n* Moderate/severe heart failure or renal impairment.\n* Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes.\n* Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization.\n* Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.)\n* Known hypersensitivity to the product components'}, 'identificationModule': {'nctId': 'NCT01499420', 'briefTitle': 'A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Limited'}, 'officialTitle': 'A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of CSL112 in Patients With Stable Atherothrombotic Disease', 'orgStudyIdInfo': {'id': 'CSLCT-HDL-10-70a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSL112', 'interventionNames': ['Biological: CSL112 (reconstituted high density lipoprotein)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'CSL112 (reconstituted high density lipoprotein)', 'type': 'BIOLOGICAL', 'description': 'Single escalating intravenous doses of CSL112', 'armGroupLabels': ['CSL112']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Single intravenous doses of normal saline (0.9%)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '42431', 'city': 'Madisonville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.3281, 'lon': -87.49889}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}], 'overallOfficials': [{'name': "Dr. Denise D'Andrea", 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}