Study to Assess Safety, Tolerability, and Efficacy of GMI... | NCT02744833

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

NCT02744833

Sponsor

GlycoMimetics Incorporated

Status

Terminated

Last Update Posted

Jun 14, 2019Actual

Enrollment

2Actual

Phase

Phase 1Phase 2

Conditions

Deep Venous Thrombosis

Interventions

GMI-1271
Enoxaparin Sodium (Lovenox®)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The trial was funded in part by a grant; the trial closed when the grant ended.

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Apr 8, 2016

First Submission Date that Met QC Criteria

Apr 15, 2016

First Posted Date

Apr 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 23, 2018

Certification/Extension First Submitted that Passed QC Review

Feb 23, 2018

Certification/Extension First Posted Date

Feb 28, 2018Actual

Last Update Submitted Date

Jun 12, 2019

Last Update Posted Date

Jun 14, 2019Actual

Name	Class
University of Michigan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GMI-1271	Experimental		Drug: GMI-1271
Enoxaparin Sodium (Lovenox®)	Active Comparator		Drug: Enoxaparin Sodium (Lovenox®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GMI-1271	Drug		GMI-1271
Enoxaparin Sodium (Lovenox®)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suman Sood, MD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000654285	uproleselan
C000711671	enoxaparin sodium
D017984	Enoxaparin

Ancestor Terms

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides

Browse Leaves

Not provided

Browse Branches

Not provided