Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT00911495 |
Recruitment Status :
Completed
First Posted : June 2, 2009
Results First Posted : May 3, 2013
Last Update Posted : May 11, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sickle Cell Disease | Drug: GMI-1070 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1/Phase 2 Study of the Safety, Pharmacokinetics, and Microvascular Effect of Titrating Doses of Intravenous GMI-1070, a Pan-Selectin Inhibitor, in Adults With Sickle Cell Disease |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: GMI-1070 |
Drug: GMI-1070
Intravenous GMI-1070 given as two doses over the course of one day |
- Safety as Measured by the Number of Participants With Adverse Events [ Time Frame: 28 days ]
- Total Plasma Clearance [ Time Frame: 48 hours ]
- Volume of the Central Compartment [ Time Frame: 48 hours ]
- Intercompartmental Clearance [ Time Frame: 48 hours ]
- Volume of the Peripheral Compartment [ Time Frame: 48 hours ]
- Blood Flow and Biomarkers of Adhesion [ Time Frame: 48 hours ]As an exploratory outcome mean change in microvascular blood flow from baseline to each time point was measured. Microvascular blood flow was also measured as microFI, perfused vessel density, and RBC velocity.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911495
United States, California | |
Children's Hospital & Research Center Oakland | |
Oakland, California, United States, 94609 | |
University of California at Davis, CCRC | |
Sacramento, California, United States, 95817 | |
United States, North Carolina | |
Duke Comprehensive Sickle Cell Center | |
Durham, North Carolina, United States, 27710 |
Study Director: | Helen Thackray, MD | GlycoMimetics Incorporated |
Responsible Party: | GlycoMimetics Incorporated |
ClinicalTrials.gov Identifier: | NCT00911495 |
Other Study ID Numbers: |
GMI-1070-103 |
First Posted: | June 2, 2009 Key Record Dates |
Results First Posted: | May 3, 2013 |
Last Update Posted: | May 11, 2020 |
Last Verified: | May 2020 |
Sickle Cell Disease |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |