This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).
This is an open label extension study in subjects who are 6 years of age or older with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). This study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (VOC) events in hospitalized subjects with SCD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.
Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study.
Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study, number of TEAEs over the study and rate of TEAEs per subject per Vaso-Occlusive Crisis (VOC) will be summarized overall, by system organ class and by preferred term.
Time frame: 18 months
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study.
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study, number of events of adjudicated ACS and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Time frame: 18 months
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study, number of events of adjudicated severe and/or generalized cutaneous manifestations and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Time frame: 18 months
Number (%) of subjects with serious adverse events (SAEs) over the study.
Number (%) of subjects with serious adverse events (SAEs) over the study, number of SAEs over the study and rate of SAEs per subject per VOC will be summarized overall, by system organ class and by preferred term.
Time frame: 18 months
Subject re hospitalization
Number (%) of subjects re hospitalized for VOC within 7, 14, and 30 days of most recent discharge will be provided overall. Number of re hospitalizations for VOC within 7, 14, and 30 days of most recent discharge and the rate of re hospitalization for VOC within 7, 14, and 30 days of most recent discharge per subject per VOC will be provided as well.
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University of South Alabama Women's and Children's Hospital
Mobile, Alabama, United States
Arkansas Children's Hospital Research Pharmacy
Little Rock, Arkansas, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
UC Davis Medical Center Main Hospital
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Howard University Center for Sickle Cell disease
Washington D.C., District of Columbia, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Golisano Childrens Hospital of Southwest Florida
Fort Myers, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
...and 87 more locations
Time frame: 18 months