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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Deep Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GMI-1271

Group Type EXPERIMENTAL

GMI-1271

Intervention Type DRUG

Enoxaparin Sodium (Lovenox®)

Group Type ACTIVE_COMPARATOR

Enoxaparin Sodium (Lovenox®)

Intervention Type DRUG

Interventions

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GMI-1271

Intervention Type DRUG

Enoxaparin Sodium (Lovenox®)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-75 years
* 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

* History or presence of clinically significant medical condition or disease in the opinion of the principal investigator
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

GlycoMimetics Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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GMI-1271-220

Identifier Type: -

Identifier Source: org_study_id

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