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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00911495
First received: May 27, 2009
Last updated: January 31, 2014
Last verified: May 2013

May 27, 2009
January 31, 2014
May 2009
July 2010   (final data collection date for primary outcome measure)
Safety as Measured by the Number of Participants With Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Safety as measured by changes in physical exam, lab tests, and vital signs during the study [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00911495 on ClinicalTrials.gov Archive Site
  • Total Plasma Clearance [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Volume of the Central Compartment [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Intercompartmental Clearance [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Volume of the Peripheral Compartment [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics, including half life and concentration of GMI-1070 in the blood [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Blood Flow and Biomarkers of Adhesion [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Blood Flow and Biomarkers of Adhesion [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
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.
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

*   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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00911495
GMI-1070-103
No
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