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

NCT02744833 | Terminated Phase 1

• 1 other identifier: GMI-1271-220
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Deep Venous Thrombosis

Keywords

DVT

Outcome Measures

Primary Outcomes (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.

  Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).

  19 days

Secondary Outcomes (4)

• 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

Study Arms (2)

GMI-1271

EXPERIMENTAL

Drug: GMI-1271

Enoxaparin Sodium (Lovenox®)

ACTIVE COMPARATOR

Drug: Enoxaparin Sodium (Lovenox®)

Interventions

GMI-1271 DRUG

GMI-1271

Enoxaparin Sodium (Lovenox®) DRUG

Enoxaparin Sodium (Lovenox®)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlycoMimetics Incorporated: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

uproleselan; enoxaparin sodium; Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Suman Sood, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 20, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

US (1)