Carilion Clinic | Research and Development
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About
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.
Enrollment
Sex
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Volunteers
Inclusion criteria
Previously participated in prior clinical study CC-93538-EE-001 and either:
OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments through the end of treatment visit
Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies.
Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the Investigator.
Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
259 participants in 1 patient group
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Central trial contact
BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.
Data sourced from clinicaltrials.gov
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