Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-31 @ 2:57 AM
Study NCT ID:
NCT00787332
Status:
TERMINATED
Last Update Posted:
2013-01-10
First Post:
2008-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C060225', 'term': 'desirudin'}, {'id': 'C031942', 'term': 'argatroban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@canyonpharma.com', 'phone': '888-434-7003', 'title': 'Director of Clinical Trials', 'organization': 'Canyon Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study stopped early due to poor enrollment.'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Desirudin', 'description': 'Patients with suspected HIT randomized to SC Desirudin i', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Argatroban®', 'description': 'Patients with suspected HIT randomized to IV Argatroban®', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'non-sustained ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'right groin hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': "elevated LFT's", 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'mild rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'esophageal hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sublingual Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'femoral graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'New Thrombosis, Amputation, Death, Major and Minor Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Desirudin', 'description': 'Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio'}, {'id': 'OG001', 'title': 'Argatroban®', 'description': 'Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients receiving drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Desirudin', 'description': 'Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio'}, {'id': 'FG001', 'title': 'Argatroban®', 'description': 'Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled between November 2008 and December 2009 from approximately 20 US Medical Centers', 'preAssignmentDetails': 'Patients were excluded if they had severe renal failure (CrCL\\<30 mL/min), known allergy to r-hirudins or argatroban, multisystem organ failure, uncontrolled bleeding.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Desirudin', 'description': 'Patients with suspected HIT randomized to SC Desirudin i'}, {'id': 'BG001', 'title': 'Argatroban®', 'description': 'Patients with suspected HIT randomized to IV Argatroban®'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '62', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '65', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-06', 'studyFirstSubmitDate': '2008-11-06', 'resultsFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2008-11-06', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-29', 'studyFirstPostDateStruct': {'date': '2008-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New Thrombosis, Amputation, Death, Major and Minor Bleeding', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Suspected Heparin Induced Thrombocytopenia (HIT)'], 'conditions': ['Suspected Heparin-Induced Thrombocytopenia']}, 'referencesModule': {'references': [{'pmid': '21079512', 'type': 'DERIVED', 'citation': 'Boyce SW, Bandyk DF, Bartholomew JR, Frame JN, Rice L. A randomized, open-label pilot study comparing desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis: PREVENT-HIT Study. Am J Ther. 2011 Jan;18(1):14-22. doi: 10.1097/MJT.0b013e3181f65503.'}, {'pmid': '20435232', 'type': 'DERIVED', 'citation': 'Frame JN, Rice L, Bartholomew JR, Whelton A. Rationale and design of the PREVENT-HIT study: a randomized, open-label pilot study to compare desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis. Clin Ther. 2010 Apr;32(4):626-36. doi: 10.1016/j.clinthera.2010.04.012.'}]}, 'descriptionModule': {'briefSummary': 'Compare Clinical Success and Costs in two Arms', 'detailedDescription': 'Demonstrate clinical and economic utility between the study Arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provide written Informed Consent\n2. Be at least 18 years of age.\n3. A suspicion of heparin-induced thrombocytopenia with or without thrombosis syndrome (HIT/TS) due to one of the following clinical scenarios:\n\n 1. Patients who are receiving heparin/LMWH or have received heparin/LMWH within the previous 100 days AND one of the following:\n\n * have a fall in platelet count of \\> 30% from a baseline prior to heparin/LMWH, OR\n * have a thrombotic event, OR\n * develop skin lesions secondary to subcutaneous heparin (even if the patient is no longer receiving heparin therapy when thrombocytopenia, thrombosis or skin lesions occur).\n\n Patients with thrombosis or skin lesions need not have concomitant thrombocytopenia to be included.\n 2. A rapid fall in the platelet count by \\>30% from baseline within 24 hours after starting heparin/LMWH in patients with suspected exposure to heparin or LMWH in the previous 100 days (e.g. hospitalization or invasive procedure within the past 100 days).\n 3. In post-operative cardiac surgery patients, development of thrombocytopenia defined as a decrease in platelet count by \\>30% from the post-operative peak; or patients whose platelet count fails to increase post-operatively (e.g. remains \\< 100,000 mm3 at Day 4 or later, calendar day of surgery=Day 0).\n4. In patients with the diagnosis of HIT/TS established by a hematology consultant, but in whom the above criteria are not fulfilled, the Investigator should contact the Medical Monitor for consideration of the patient's inclusion in this study (A hematology consult is highly advisable, but not required prior to randomization).\n\nExclusion Criteria:\n\n* Confirmed pregnancy (if woman of child-bearing potential- urine or serum pregnancy test).\n* Patients with suspected or confirmed pulmonary embolism, requiring continued anticoagulation or acute ischemic stroke will be excluded\n* Cerebrovascular accident within the previous 6 months\n* Intracranial neoplasm, arteriovenous malformation or aneurysm.\n* Severe renal insufficiency as determined by measured or estimated creatinine clearance \\< 30 ml/min.\n* Known allergy to Argatroban®, Desirudin or hirudin derived drugs, or known sensitivity to any component of the product\n* Patients receiving recombinant hirudin (e.g. lepirudin) within the previous 6 months prior to enrollment.\n* Patients receiving \\>2 doses of fondaparinux for treatment of suspected HIT\n* Multi-system organ failure or estimated survival of less than 30 days.\n* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment\n* Refusal to undergo blood transfusion should it become necessary\n* Active bleeding or irreversible coagulation abnormality\n* Uncontrolled hypertension defined as a blood pressure \\>180/110 mm Hg.\n* Patients requiring indwelling mechanical intervention such as left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration, etc.\n* Severe liver disease and any other disease or condition, which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial."}, 'identificationModule': {'nctId': 'NCT00787332', 'acronym': 'HIT', 'briefTitle': 'A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Canyon Pharmaceuticals, Inc.'}, 'officialTitle': 'A Comparative Clinical and Pharmacoeconomic Study Comparing Argatroban® IV vs Desirudin SC for Patients With Suspected Heparin-Induced Thrombocytopenia (HIT)With or Without Thrombosis Syndrome (HIT/TS)', 'orgStudyIdInfo': {'id': 'DES-08-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desirudin', 'description': 'Patients with suspected HIT without thrombosis syndrome (HIT/TS), randomized to SC Desirudin', 'interventionNames': ['Drug: Desirudin or Argatroban®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Argatroban®', 'description': 'Patients randomized to IV Argatroban®', 'interventionNames': ['Drug: Desirudin or Argatroban®']}], 'interventions': [{'name': 'Desirudin or Argatroban®', 'type': 'DRUG', 'description': 'Desirudin 15mg SC Argatroban® IV dosing per Package Insert', 'armGroupLabels': ['Argatroban®', 'Desirudin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Science Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Regional Cardiac Surgery', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cardiovascular Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida, Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University, Emory Crawford Long Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96819', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': "Provena St. Joseph's Medical Center", 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': "St Mary's Hospital Rochester, Mayo Clinic", 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ-Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10011', 'city': 'Manhattan', 'state': 'New York', 'country': 'United States', 'facility': "St Vincent's Hosptial -Manhattan", 'geoPoint': {'lat': 40.78343, 'lon': -73.96625}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Clinical & Translational Research Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center, Moses Division', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '55902', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forsyth Regional Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '42314', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cardiothoracic Vascular Surgial Specialists', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Charleston Area Medical Center', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'overallOfficials': [{'name': 'Dawn Bell, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Canyon Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canyon Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}