Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 12:06 PM
Study NCT ID:
NCT00243308
Status:
TERMINATED
Last Update Posted:
2009-02-06
First Post:
2005-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serp-1 for the Treatment of Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-07-07', 'releaseDate': '2011-06-09'}], 'estimatedResultsFirstSubmitDate': '2011-06-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023903', 'term': 'Coronary Restenosis'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'whyStopped': 'Third dose group not recruited due to slow enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-10'}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-05', 'studyFirstSubmitDate': '2005-10-19', 'studyFirstSubmitQcDate': '2005-10-19', 'lastUpdatePostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Adverse events collected until 6 months post-dose)'}], 'secondaryOutcomes': [{'measure': 'Inflammatory marker analysis'}, {'measure': 'MACE'}, {'measure': 'Restenosis at 6 months'}]}, 'conditionsModule': {'keywords': ['Anti-inflammatory agents', 'unstable plaque', 'acute coronary syndrome'], 'conditions': ['Unstable Angina', 'Coronary Atherosclerosis', 'Coronary Restenosis']}, 'referencesModule': {'references': [{'pmid': '21062996', 'type': 'DERIVED', 'citation': "Tardif JC, L'Allier PL, Gregoire J, Ibrahim R, McFadden G, Kostuk W, Knudtson M, Labinaz M, Waksman R, Pepine CJ, Macaulay C, Guertin MC, Lucas A. A randomized controlled, phase 2 trial of the viral serpin Serp-1 in patients with acute coronary syndromes undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2010 Dec;3(6):543-8. doi: 10.1161/CIRCINTERVENTIONS.110.953885. Epub 2010 Nov 9."}]}, 'descriptionModule': {'briefSummary': 'Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.', 'detailedDescription': 'A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for ACS. Serp-1 will be administered as a single IV bolus injection. The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission\n* Scheduled for PCI\n\nExclusion Criteria:\n\n* CABG within 6 months\n* Acute ST elevation, eligible for thrombolysis on initial examination\n* Coronary lesions with total thrombotic occlusions\n* Current immunosuppressant therapy'}, 'identificationModule': {'nctId': 'NCT00243308', 'briefTitle': 'Serp-1 for the Treatment of Acute Coronary Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viron Therapeutics Inc'}, 'officialTitle': 'A Phase 2, Multicentre, Double-Blind, Placebo-Controlled, Dose Escalating Trial of the Safety, Pharmacokinetics, and Biological Activity of 3 Consecutive Daily Doses of Serp-1 When Added to Conventional Therapy in Patients With Acute Coronary Syndromes (Non ST-Elevation Myocardial Infarction and/or Unstable Angina)', 'orgStudyIdInfo': {'id': 'Serp-1-01-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Serine proteinase-1 (Serp-1)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610-0277', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '49525', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': 'V8R 4R2', 'city': 'Vicotria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria Heart Institute'}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Foothills Medical Center'}, {'zip': 'N6A 5C1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Alexandra Lucas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief Clinical Officer- Viron Therapeutics'}, {'name': 'Jean-Claude Tardif, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Director- Montreal Heart Institute Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viron Therapeutics Inc', 'class': 'INDUSTRY'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-06-09', 'type': 'RELEASE'}, {'date': '2011-07-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Viron Therapeutics (Dr. Claude Benedict, MD. / Senior VP Clinical Development and Regulatory Affairs)'}}}}