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

NCT00911495 | Completed Phase 1 Results

• 1 other identifier: GMI-1070-103
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Safety as Measured by the Number of Participants With Adverse Events

  28 days

Secondary Outcomes (4)

• Total Plasma Clearance

  48 hours

• Volume of the Central Compartment

  48 hours

• Intercompartmental Clearance

  48 hours

• Volume of the Peripheral Compartment

  48 hours

Other Outcomes (1)

• Blood Flow and Biomarkers of Adhesion

  48 hours

Study Arms (1)

GMI-1070

EXPERIMENTAL

Drug: GMI-1070

Interventions

GMI-1070 DRUG

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

GMI-1070

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlycoMimetics Incorporated: lead

Study Sites (3)

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

University of California at Davis, CCRC

Sacramento, California, 95817, United States

Location

Duke Comprehensive Sickle Cell Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 24988449 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

rivipansel

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Helen Thackray, MD

  GlycoMimetics Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: June 2, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 11, 2020
• Results First Posted: May 3, 2013

Record last verified: 2020-05

Locations

US (3)