Name of Study: Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects with Sickle Cell Disease – Extension study
Brief 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).
Intervention – Drug: Rivipansel
Age range: There are 2 cohorts in this study
Cohort 1: includes one adult stratum (18 years old) and one pediatric stratum (12-17 years old)
Cohort 2: includes one pediatric stratum (6-11 years old)
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 the administration of the first dose of IV opioids for this hospitalization.
Exclusion Criteria: Non-compliance with study procedures in the double-blind study (B5201002). The 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.
Sites in Ontario:
1. Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada, K1H 8L1
2. The Hospital for Sick Children, Toronto, Ontario, Canada, M5G 1X8
Status: Recruiting
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Source: clinical trials.gov Identifier #: NCT02433158
Last updated: May 31st, 2018