Clinical Trial
Study Details
Single two-hour infusion of SANGUINATE
Single two-hour infusion of placebo
Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis
Study Overview
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
FSCDR
Hollywood, Florida 33021
United States
Florida Health Tampa General Hospital
Tampa, Florida 33606
United States
University of Maryland School of Medicine
Baltimore, Maryland 21201-1559
United States
Johns Hopkins Univeristy School of Medicine
Baltimore, Maryland 21205
United States
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United States
University of Rochester Medical Center
Rochester, New York 14627-0140
United States
Ohio State University Medical Center
Columbus, Ohio 43203
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Blood Center of Wisconsin
Milwaukee, Wisconsin 53226
United States