Status:
COMPLETED
Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
Lead Sponsor:
GlycoMimetics Incorporated
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
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 int...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00911495
Start Date
May 1 2009
End Date
September 1 2010
Last Update
May 11 2020
Active Locations (3)
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1
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
2
University of California at Davis, CCRC
Sacramento, California, United States, 95817
3
Duke Comprehensive Sickle Cell Center
Durham, North Carolina, United States, 27710