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



Status:Completed
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/26/2017
Start Date:July 2016
End Date:November 2016

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A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis

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).


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
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Suman Sood, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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