Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)
NCT ID: NCT02744833
Last Updated: 2019-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2016-07-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GMI-1271
GMI-1271
Enoxaparin Sodium (Lovenox®)
Enoxaparin Sodium (Lovenox®)
Interventions
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GMI-1271
Enoxaparin Sodium (Lovenox®)
Eligibility Criteria
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Inclusion Criteria
* Male or female
* Diagnosed with acute isolated calf vein Deep Venous Thrombosis (DVT)
* Willing and able to participate in all required evaluations and procedures in this study protocol
Exclusion Criteria
* Uncontrolled acute life-threatening bacterial, viral or fungal infection
* Unable to be treated with systemic anticoagulants
* Current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics
* Diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years
* Current or recent cancer treatment
* Major surgery within 21 days or planned surgery during the study period
* Female subjects who are pregnant or breastfeeding
* Known history of HIV, Hepatitis B or Hepatitis C
* Alcoholism or drug use
* Clinically significant cardiovascular disease
18 Years
75 Years
ALL
No
Sponsors
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University of Michigan
OTHER
GlycoMimetics Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Suman Sood, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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GMI-1271-220
Identifier Type: -
Identifier Source: org_study_id
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