Trials / Recruiting
RecruitingNCT06143514
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 16 (estimated)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No intervention |
Timeline
- Start date
- 2024-03-26
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2023-11-22
- Last updated
- 2026-04-07
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06143514. Inclusion in this directory is not an endorsement.