A Phase 1/2 interventional study of GMI-1271 and Enoxaparin Sodium (Lovenox®) in Deep Venous Thrombosis, sponsored by GlycoMimetics Incorporated. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by GlycoMimetics Incorporated · Phase 1/2, Interventional, and Treatment
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).
787 studies on the registry are indexed under Venous Thrombosis; 123 are open to participants now.
This study's enrollment of 2 is below the median of 131 across 463 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →GlycoMimetics Incorporated is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: GMI-1271
Drug: Enoxaparin Sodium (Lovenox®)
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.
Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).
Time frame: 19 days
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
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Uproleselan
GlycoMimetics Incorporated