Summary
This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).
Conditions
Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
Recruitment Status
TERMINATED
Detailed Description
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.
Eligibility Criteria
Inclusion Criteria:
* Completion of Study B5201002.
* Documented diagnosis of SCD.
* At least 6 years of age.
* Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.
* Diagnosis of VOC necessitating IV opioids and admission to the hospital.
* Able to receive the first dose of rivipansel within 24 hours from administration of the first dose of IV opioids for this hospitalization.
Exclusion Criteria:
* Non-compliance with study procedures in the double blind study (B5201002).
* Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
* Clinically significant deterioration in renal function in Study B5201002.
* Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
* Active use of illicit drugs and/or alcohol dependence.
Intervention
Intervention Type
Intervention Name
DRUG
Rivipansel
Phase
PHASE3
Gender
ALL
Min Age
6 Years
Max Age
N/A
Download Date
2021-02-10
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: