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Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

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NCT00911495

Last updated on December 7, 2019
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FOR MORE INFORMATION
Study Location
Children's Hospital & Research Center Oakland
Oakland, California, 94609 United States
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Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sickle Cell Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00911495
Pfizer
Completed
Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

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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 SummaryThis 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 DescriptionNot 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 DateJuly 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Helen Thackray, MDGlycoMimetics Incorporated
PRS AccountPfizer
Verification DateMay 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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