Skip to main content
OpenTrials
Completed

NCT Number: NCT00911495

Study of Intravenous GMI-1070 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Children's Hospital & Research Center Oakland, Oakland, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GMI-1070

Drug

Intravenous GMI-1070 given as two doses over the course of one day

Primary outcomes

  1. Safety as Measured by the Number of Participants With Adverse Events

    Time frame: 28 days

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2009
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.