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.
(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.