Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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. [ Time Frame: 19 days ]
Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).
Secondary Outcome Measures :
To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound [ Time Frame: 19 days ]
To evaluate the effects of GMI-1271 on the incidence of bleeding time [ Time Frame: 19 days ]
To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT) [ Time Frame: 19 days ]
To evaluate the effects of GMI-1271 on biomarkers of coagulation [ Time Frame: 19 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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