Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

Phase 1

Completed

• Conditions: Sickle Cell Disease
• Interventions: Drug: GMI-1070

• Registration Number: NCT00911495
• Lead Sponsor: GlycoMimetics Incorporated

Brief Summary

This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-27
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-02
• Primary Completion: 2010-07
• Study Completion: 2010-09
• Results First Submitted: 2012-09-11
• Results First Submitted QC: 2013-05-02
• Results First Posted: 2013-05-03
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age 18 to 45 years
• Established diagnosis of SCD-SS or SCD-SB0-thal
• At medical baseline, with no evidence of worsening of disease over the last 3 months
• Available and agree to return for follow-up visits for the full duration of the study
• Able to cooperate with study procedures
• Documented and observed written informed consent

Exclusion Criteria

• Vaso-occlusive crisis
• Recent major surgery, hospitalization, infection, significant bleeding, cerebrovascular accident or seizure, or transfusion
• Currently receiving, or has received within the previous 4 weeks, any other investigational agent
• Pregnant or lactating female; or female of childbearing age unable or unwilling to comply with birth control or abstinence during the course of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GMI-1070	GMI-1070	-

Primary Outcome Measures

Name	Time	Method
Safety as Measured by the Number of Participants With Adverse Events	28 days

Secondary Outcome Measures

Name	Time	Method
Volume of the Peripheral Compartment	48 hours
Total Plasma Clearance	48 hours
Volume of the Central Compartment	48 hours
Intercompartmental Clearance	48 hours

Trial Locations

Locations (3)

Duke Comprehensive Sickle Cell Center; 🇺🇸 Durham, North Carolina, United States

Children's Hospital & Research Center Oakland; 🇺🇸 Oakland, California, United States

University of California at Davis, CCRC; 🇺🇸 Sacramento, California, United States