Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT02433158
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT02433158
Study Brief:
Protocol Section:
NCT02433158