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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

Tracking Information
First Submitted Date  ICMJE May 27, 2009
First Posted Date  ICMJE June 2, 2009
Results First Submitted Date  ICMJE September 11, 2012
Results First Posted Date  ICMJE May 3, 2013
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE May 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
Safety as Measured by the Number of Participants With Adverse Events [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
Safety as measured by changes in physical exam, lab tests, and vital signs during the study [ Time Frame: 7 days ]
Change History Complete list of historical versions of study NCT00911495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
  • Pharmacokinetics, including half life and concentration of GMI-1070 in the blood [ Time Frame: 48 hours ]
  • Blood Flow and Biomarkers of Adhesion [ Time Frame: 48 hours ]
Current Other Pre-specified Outcome Measures
 (submitted: May 2, 2013)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Drug: GMI-1070
Intravenous GMI-1070 given as two doses over the course of one day
Study Arms  ICMJE Experimental: GMI-1070
Intervention: Drug: GMI-1070
Publications * Wun T, Styles L, DeCastro L, Telen MJ, Kuypers F, Cheung A, Kramer W, Flanner H, Rhee S, Magnani JL, Thackray H. Phase 1 study of the E-selectin inhibitor GMI 1070 in patients with sickle cell anemia. PLoS One. 2014 Jul 2;9(7):e101301. doi: 10.1371/journal.pone.0101301. eCollection 2014. Erratum in: PLoS One. 2014;9(10):e111690.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2012)
15
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2009)
20
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00911495
Other Study ID Numbers  ICMJE GMI-1070-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Helen Thackray, MD GlycoMimetics Incorporated
PRS Account Pfizer
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP