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 |
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).
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
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...
Click here to add this to my saved trials