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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 : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: GMI-1070 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: GMI-1070 Drug: GMI-1070
Intravenous GMI-1070 given as two doses over the course of one day


Outcome Measures
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Primary Outcome Measures :
  1. Safety as Measured by the Number of Participants With Adverse Events [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Total Plasma Clearance [ Time Frame: 48 hours ]
  2. Volume of the Central Compartment [ Time Frame: 48 hours ]
  3. Intercompartmental Clearance [ Time Frame: 48 hours ]
  4. Volume of the Peripheral Compartment [ Time Frame: 48 hours ]

Other Outcome Measures:
  1. 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.


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

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
Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Helen Thackray, MD GlycoMimetics Incorporated
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00911495     History of Changes
Other Study ID Numbers: GMI-1070-103
First Posted: June 2, 2009    Key Record Dates
Results First Posted: May 3, 2013
Last Update Posted: September 23, 2016
Last Verified: May 2013
Keywords provided by Pfizer:
Sickle Cell Disease
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn