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

Phase 1

Terminated

• Conditions: Deep Venous Thrombosis
• Interventions: Drug: Enoxaparin Sodium (Lovenox®); Drug: GMI-1271

• Registration Number: NCT02744833
• Lead Sponsor: GlycoMimetics Incorporated

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Study Start: 2016-07
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Disposition First Submitted: 2018-02-23
• Disposition First Submitted QC: 2018-02-23
• Disposition First Posted: 2018-02-28
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin Sodium (Lovenox®)	Enoxaparin Sodium (Lovenox®)	-
GMI-1271	GMI-1271	-

Primary Outcome Measures

Name	Time	Method
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.	19 days	Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States