Overview

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

Status:
Terminated
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlycoMimetics Incorporated
Collaborator:
University of Michigan
Treatments:
Enoxaparin
Enoxaparin sodium
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