- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00911495
Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
May 7, 2020 updated by: GlycoMimetics Incorporated
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oakland, California, United States, 94609
- Children's Hospital & Research Center Oakland
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Sacramento, California, United States, 95817
- University of California at Davis, CCRC
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Sickle Cell Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GMI-1070
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Intravenous GMI-1070 given as two doses over the course of one day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety as Measured by the Number of Participants With Adverse Events
Time Frame: 28 days
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28 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Plasma Clearance
Time Frame: 48 hours
|
48 hours
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Volume of the Central Compartment
Time Frame: 48 hours
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48 hours
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Intercompartmental Clearance
Time Frame: 48 hours
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48 hours
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Volume of the Peripheral Compartment
Time Frame: 48 hours
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48 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Helen Thackray, MD, GlycoMimetics Incorporated
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
May 27, 2009
First Submitted That Met QC Criteria
May 29, 2009
First Posted (Estimate)
June 2, 2009
Study Record Updates
Last Update Posted (Actual)
May 11, 2020
Last Update Submitted That Met QC Criteria
May 7, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMI-1070-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on GMI-1070
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GlycoMimetics IncorporatedCompleted
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GlycoMimetics IncorporatedCompletedSickle Cell Disease | Vaso-occlusive Crisis | Pain CrisisUnited States, Canada
-
GlycoMimetics IncorporatedCompletedAnemia, Sickle CellUnited States, Canada
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GlycoMimetics IncorporatedCompleted
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GlycoMimetics IncorporatedCompletedHealthy Adult SubjectsUnited States
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GlycoMimetics IncorporatedTerminatedBreast Cancer | Breast Cancer Metastatic | HR+ Metastatic Breast CancerUnited States
-
St. Ambrose UniversityCompleted