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Trial record 2 of 6 for:    gmi-1271

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

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ClinicalTrials.gov Identifier: NCT02744833
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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).

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Drug: GMI-1271 Drug: Enoxaparin Sodium (Lovenox®) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis
Actual Study Start Date : July 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GMI-1271 Drug: GMI-1271
Active Comparator: Enoxaparin Sodium (Lovenox®) Drug: Enoxaparin Sodium (Lovenox®)



Primary Outcome Measures :
  1. 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 :
  1. To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound [ Time Frame: 19 days ]
  2. To evaluate the effects of GMI-1271 on the incidence of bleeding time [ Time Frame: 19 days ]
  3. To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT) [ Time Frame: 19 days ]
  4. To evaluate the effects of GMI-1271 on biomarkers of coagulation [ Time Frame: 19 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744833


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
GlycoMimetics Incorporated
University of Michigan
Investigators
Principal Investigator: Suman Sood, MD University of Michigan

Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02744833     History of Changes
Other Study ID Numbers: GMI-1271-220
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by GlycoMimetics Incorporated:
DVT

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action