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