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

• Sponsor: GlycoMimetics Incorporated (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02744833
• Collaborator: University of Michigan (Other)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 0.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Deep Venous Thrombosis	Drug: GMI-1271; Drug: Enoxaparin Sodium (Lovenox®)	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound [19 days]

2. To evaluate the effects of GMI-1271 on the incidence of bleeding time [19 days]

3. To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT) [19 days]

4. To evaluate the effects of GMI-1271 on biomarkers of coagulation [19 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• GlycoMimetics Incorporated
• University of Michigan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlycoMimetics Incorporated
• ClinicalTrials.gov Identifier: NCT02744833
• Other Study ID Numbers: GMI-1271-220
• First Posted: Apr 20, 2016
• Last Update Posted: Jun 14, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by GlycoMimetics Incorporated: DVT
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis; Enoxaparin; Enoxaparin sodium

Study Results

No Results Posted as of Jun 14, 2019