Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)

June 12, 2019 updated by: GlycoMimetics Incorporated

A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GMI-1271
Drug: GMI-1271
Active Comparator: Enoxaparin Sodium (Lovenox®)
Drug: Enoxaparin Sodium (Lovenox®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 19 days
Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).
19 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound
Time Frame: 19 days
19 days
To evaluate the effects of GMI-1271 on the incidence of bleeding time
Time Frame: 19 days
19 days
To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)
Time Frame: 19 days
19 days
To evaluate the effects of GMI-1271 on biomarkers of coagulation
Time Frame: 19 days
19 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlycoMimetics Incorporated

Collaborators

University of Michigan

Investigators

  • Principal Investigator: Suman Sood, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMI-1271-220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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