Title
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
Phase
Phase 1/Phase 2Lead Sponsor
PfizerStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Sickle Cell DiseaseIntervention/Treatment
rivipansel ...Study Participants
15This 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.
Intravenous GMI-1070 given as two doses over the course of one day
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
| Event Type | Organ System | Event Term | GMI-1070 |
|---|
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.
Outcome Measure Data Not Reported
