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

G

GlycoMimetics

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Deep Venous Thrombosis

Treatments

Drug: Enoxaparin Sodium (Lovenox®)
Drug: GMI-1271

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02744833
GMI-1271-220

Details and patient eligibility

About

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).

Enrollment

2 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

GMI-1271
Experimental group
Treatment:
Drug: GMI-1271
Enoxaparin Sodium (Lovenox®)
Active Comparator group
Treatment:
Drug: Enoxaparin Sodium (Lovenox®)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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