Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis

Clinical Trial
Study Details
Enrollment
24
Interventions
Description

Single two-hour infusion of SANGUINATE

Name
SANGUINATE
Type
Drug
Description

Single two-hour infusion of placebo

Name
Placebo
Type
Drug
Phase
Phase 2
Status
COMPLETED
Study ID #
NCT02411708
Study Type
Interventional
Summary

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis

Study Overview
Conditions
Description

Patients who are experiencing a vaso-occlusive crisis will report to the clinic for treatment and screening into the SGSC-005 study. Patients who meet all inclusion/exclusion criteria will be randomized to receive either SANGUINATE 320 mg/kg or placebo (saline) over a 2 hour infusion period. Assessments of vital signs, ECGs, safety labs, adverse events as well as patient and physician questionnaires will be completed up to 6 hours after the start of the infusion. Patients will then be assessed for discharge either to home or admitted to the hospital for further treatment depending on their disease severity. Follow-up phone calls will be completed 24 hours and 7 days after initiation of treatment . A follow-up visit will be completed in the clinic at 72 hours after initiation of treatment.

Contacts and Locations
Locations
Facility

FSCDR
Hollywood, Florida 33021
United States

GeoPoint
26.0112, -80.14949
Facility

Florida Health Tampa General Hospital
Tampa, Florida 33606
United States

GeoPoint
27.94752, -82.45843
Facility

University of Maryland School of Medicine
Baltimore, Maryland 21201-1559
United States

GeoPoint
39.29038, -76.61219
Facility

Johns Hopkins Univeristy School of Medicine
Baltimore, Maryland 21205
United States

GeoPoint
39.29038, -76.61219
Facility

Newark Beth Israel Medical Center
Newark, New Jersey 07112
United States

GeoPoint
40.73566, -74.17237
Facility

University of Rochester Medical Center
Rochester, New York 14627-0140
United States

GeoPoint
43.15478, -77.61556
Facility

Ohio State University Medical Center
Columbus, Ohio 43203
United States

GeoPoint
39.96118, -82.99879
Facility

Virginia Commonwealth University
Richmond, Virginia 23298
United States

GeoPoint
37.55376, -77.46026
Facility

Blood Center of Wisconsin
Milwaukee, Wisconsin 53226
United States

GeoPoint
43.0389, -87.90647