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

Deep Venous Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02744833
• Other study ID #: GMI-1271-220
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: June 2019
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• GMI-1271

• Enoxaparin Sodium (Lovenox®)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	19 days
Secondary	To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound		19 days
Secondary	To evaluate the effects of GMI-1271 on the incidence of bleeding time		19 days
Secondary	To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)		19 days
Secondary	To evaluate the effects of GMI-1271 on biomarkers of coagulation		19 days