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

Completed · Phase 1/Phase 2

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT00911495

Run by

GlycoMimetics Incorporated

People needed

15

Starts

2009-05-01

Expected to finish

2010-09-01

Last updated by the study team

2020-05-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital & Research Center Oakland — Oakland, California, United States
• University of California at Davis, CCRC — Sacramento, California, United States
• Duke Comprehensive Sickle Cell Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.