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A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
Sponsor: TG Therapeutics, Inc.
Summary
The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).
Official title: A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
16
Start Date
2024-03-26
Completion Date
2026-06-30
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
No intervention
No intervention
Locations (5)
PROVIDE Virtual Research Coordination Center
San Francisco, California, United States
PROVIDE Virtual Research Coordination Center
Smyrna, Georgia, United States
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States
PROVIDE Virtual Research Coordination Center
Wilmington, North Carolina, United States
PROVIDE Virtual Research Coordination Center
Nashville, Tennessee, United States