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

Primary Purpose

Deep Venous Thrombosis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GMI-1271

Enoxaparin Sodium (Lovenox®)

About this trial

This is an interventional treatment trial for Deep Venous Thrombosis focused on measuring DVT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GMI-1271

Enoxaparin Sodium (Lovenox®)

Arm Description

Outcomes

Primary Outcome Measures

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.

Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).

Secondary Outcome Measures

To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound

To evaluate the effects of GMI-1271 on the incidence of bleeding time

To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)

To evaluate the effects of GMI-1271 on biomarkers of coagulation

Full Information

NCT ID

NCT02744833

First Posted

April 8, 2016

Last Updated

June 12, 2019

Sponsor

GlycoMimetics Incorporated

Collaborators

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT02744833

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

The trial was funded in part by a grant; the trial closed when the grant ended.

Study Start Date

July 2016 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlycoMimetics Incorporated

Collaborators

University of Michigan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Venous Thrombosis

Keywords

DVT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GMI-1271

Arm Type

Experimental

Arm Title

Enoxaparin Sodium (Lovenox®)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

GMI-1271

Intervention Type

Drug

Intervention Name(s)

Enoxaparin Sodium (Lovenox®)

Primary Outcome Measure Information:

Title

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.

Description

Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).

Time Frame

19 days

Secondary Outcome Measure Information:

Title

To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound

Time Frame

19 days

Title

To evaluate the effects of GMI-1271 on the incidence of bleeding time

Time Frame

19 days

Title

To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)

Time Frame

19 days

Title

To evaluate the effects of GMI-1271 on biomarkers of coagulation

Time Frame

19 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suman Sood, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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