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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Deep Venous Thrombosis

Intervention / Treatment
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* Drug: GMI-1271
* Drug: Enoxaparin Sodium (Lovenox®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GMI-1271<br> | Drug: GMI-1271<br> <br> |
| Active Comparator: Enoxaparin Sodium (Lovenox®)<br> | Drug: Enoxaparin Sodium (Lovenox®)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 19 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound |  | 19 days | 
| To evaluate the effects of GMI-1271 on the incidence of bleeding time |  | 19 days | 
| To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT) |  | 19 days | 
| To evaluate the effects of GMI-1271 on biomarkers of coagulation |  | 19 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DVT