Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT00943267
Status:
COMPLETED
Last Update Posted:
2011-03-16
First Post:
2009-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Intrapulmonary Recombinant Human Activated Protein C (APC) on Coagulation and Inflammation After Lipopolysaccharide (LPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-01-07', 'releaseDate': '2018-06-25'}], 'estimatedResultsFirstSubmitDate': '2018-06-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D004731', 'term': 'Endotoxins'}, {'id': 'D001999', 'term': 'Bronchoscopy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-15', 'studyFirstSubmitDate': '2009-07-21', 'studyFirstSubmitQcDate': '2009-07-21', 'lastUpdatePostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether direct intrapulmonary delivery of rhAPC can inhibit LPS-induced lung inflammation, thereby avoiding systemic APC effects', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': '1. Neutrophil responses 2. Response of alveolar macrophages 3. Activation of the cytokine and chemokine network 4. Activation of coagulation and fibrinolysis', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Activated Protein C', 'Lipopolysaccharides', 'Inflammation, Pulmonary'], 'conditions': ['Pneumonia', 'Lipopolysaccharides']}, 'referencesModule': {'references': [{'pmid': '23060625', 'type': 'DERIVED', 'citation': "Kager LM, de Boer JD, Bresser P, van der Zee JS, Zeerleder S, Meijers JC, van 't Veer C, van der Poll T. Intrabronchial activated protein C enhances lipopolysaccharide-induced pulmonary responses. Eur Respir J. 2013 Jul;42(1):188-97. doi: 10.1183/09031936.00057112. Epub 2012 Oct 11."}]}, 'descriptionModule': {'briefSummary': 'Recombinant human Activated Protein C (rhAPC) has been shown to reduce the mortality of patients with severe sepsis. The biological effects of APC are pleiotropic, and can be roughly divided in anticoagulant and cytoprotective effects. Lung infection and inflammation are associated with reduced bronchoalveolar levels of endogenous APC. Recent evidence derived from animal studies indicates that local administration of rAPC into the lungs exerts local anti-inflammatory and anticoagulant effects. In this study we propose to study the potential of locally administered APC, within a lung subsegment, to inhibit lipopolysaccharide (LPS) induced lung inflammation and coagulation in humans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, 18-35 years of age\n* No clinically significant findings during physical examination and hematological and biochemical screening\n* Normal spirometry and ECG\n* Able to communicate well with the investigator and to comply with the requirements of the study\n* No medication\n* Written informed consent\n* No smoking\n\nExclusion criteria:\n\n* Known diseases\n* A history of smoking within the last six months, or regular consumption of greater than three units of alcohol per day\n* Administration of any investigational drug within 30 days of study initiation\n* Donation of blood within 60 days, or loss of greater than 400 ml of blood within 12 weeks of study initiation\n* History of enhanced bleeding tendency\n* History of heparin-induced thrombocytopenia\n* History of serious drug-related reactions, including hypersensitivity'}, 'identificationModule': {'nctId': 'NCT00943267', 'briefTitle': 'Effect of Intrapulmonary Recombinant Human Activated Protein C (APC) on Coagulation and Inflammation After Lipopolysaccharide (LPS)', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Effect of Intrapulmonary Administration of Recombinant Human Activated Protein C on Local Coagulation and Inflammation After Bronchial Instillation of Lipopolysaccharide in Humans', 'orgStudyIdInfo': {'id': 'CEMM-APC-01'}, 'secondaryIdInfos': [{'id': 'MEC 08/188'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Activated protein C', 'interventionNames': ['Drug: Drotrecogin alpha', 'Drug: Endotoxin', 'Procedure: Bronchoscopy', 'Procedure: Blood sampling']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Drug: Saline (NaCl 0.9%)', 'Drug: Endotoxin', 'Procedure: Bronchoscopy', 'Procedure: Blood sampling']}], 'interventions': [{'name': 'Drotrecogin alpha', 'type': 'DRUG', 'description': 'Drotrecogin alpha is given intrabronchially by bronchoscopy at t=0', 'armGroupLabels': ['Activated protein C']}, {'name': 'Saline (NaCl 0.9%)', 'type': 'DRUG', 'description': 'Normal saline is given intrabronchially by bronchoscopy at t=0', 'armGroupLabels': ['Saline']}, {'name': 'Endotoxin', 'type': 'DRUG', 'description': 'Endotoxin (4 ng/kg body weight) is given intrabronchially in one subsegment at t=0', 'armGroupLabels': ['Activated protein C', 'Saline']}, {'name': 'Bronchoscopy', 'type': 'PROCEDURE', 'description': 'Bronchoscopies are performed at t=0 (for instillation of LPS and Drotrecogin alpha) and at t=6 (for performing a bronchoalveolar lavage)', 'armGroupLabels': ['Activated protein C', 'Saline']}, {'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'Blood sampling is done by venapuncture at t=0 and t=6', 'armGroupLabels': ['Activated protein C', 'Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1100DD', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center/ University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Tom Van der Poll, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMC/UvA Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Tom van der Poll MD PhD', 'oldOrganization': 'Center for Experimental Molecular Medicine, AMC-UvA, Amsterdam, The Netherlands'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-06-25', 'type': 'RELEASE'}, {'date': '2019-01-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'T. van der Poll, Prof dr, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}