Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-27 @ 8:52 AM
Study NCT ID:
NCT02744833
Status:
TERMINATED
Last Update Posted:
2019-06-14
First Post:
2016-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654285', 'term': 'uproleselan'}, {'id': 'C000711671', 'term': 'enoxaparin sodium'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'The trial was funded in part by a grant; the trial closed when the grant ended.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'dispFirstSubmitDate': '2018-02-23', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2016-04-08', 'dispFirstSubmitQcDate': '2018-02-23', 'studyFirstSubmitQcDate': '2016-04-15', 'dispFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of GMI-1271 in patients with calf-level DVT by assessment with vital signs, standard laboratory blood tests, electrocardiogram, and adverse event evaluation.', 'timeFrame': '19 days', 'description': 'Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound', 'timeFrame': '19 days'}, {'measure': 'To evaluate the effects of GMI-1271 on the incidence of bleeding time', 'timeFrame': '19 days'}, {'measure': 'To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)', 'timeFrame': '19 days'}, {'measure': 'To evaluate the effects of GMI-1271 on biomarkers of coagulation', 'timeFrame': '19 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DVT'], 'conditions': ['Deep Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution in patients with distal calf vein Deep Venous Thrombosis (DVT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Male or female\n* Diagnosed with acute isolated calf vein Deep Venous Thrombosis (DVT)\n* Willing and able to participate in all required evaluations and procedures in this study protocol\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical condition or disease in the opinion of the principal investigator\n* Uncontrolled acute life-threatening bacterial, viral or fungal infection\n* Unable to be treated with systemic anticoagulants\n* Current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics\n* Diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years\n* Current or recent cancer treatment\n* Major surgery within 21 days or planned surgery during the study period\n* Female subjects who are pregnant or breastfeeding\n* Known history of HIV, Hepatitis B or Hepatitis C\n* Alcoholism or drug use\n* Clinically significant cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT02744833', 'briefTitle': 'Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlycoMimetics Incorporated'}, 'officialTitle': 'A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis', 'orgStudyIdInfo': {'id': 'GMI-1271-220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GMI-1271', 'interventionNames': ['Drug: GMI-1271']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin Sodium (Lovenox®)', 'interventionNames': ['Drug: Enoxaparin Sodium (Lovenox®)']}], 'interventions': [{'name': 'GMI-1271', 'type': 'DRUG', 'armGroupLabels': ['GMI-1271']}, {'name': 'Enoxaparin Sodium (Lovenox®)', 'type': 'DRUG', 'armGroupLabels': ['Enoxaparin Sodium (Lovenox®)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Suman Sood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlycoMimetics Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}