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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02744833

Enrollment

Registered

2016-04-20

Start date

2016-07-31

Completion date

2016-11-30

Last updated

2019-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Venous Thrombosis

Keywords

DVT

Brief summary

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).

Interventions

DRUGGMI-1271

DRUGEnoxaparin Sodium (Lovenox®)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.	19 days	Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026