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RECRUITING
NCT06143514

A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk

Sponsor: TG Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

OTHER

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