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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Children's Hospital & Research Center Oakland
Oakland, California, 94609 United States
Contact
1-800-718-1021
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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Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sickle Cell Disease
Drug: GMI-1070
Intravenous GMI-1070 given as two doses over the course of one day
Experimental: GMI-1070
Intervention: Drug: GMI-1070
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.
 
Completed
15
September 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00911495
GMI-1070-103
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Helen Thackray, MD GlycoMimetics Incorporated
Pfizer
May 2013

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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