Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143514
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-11-16
Brief Title:
A Study Evaluating the Presence and Concentration of BRIUMVI Ublituximab in Breast Milk
Sponsor:
TG Therapeutics Inc
Organization:
TG Therapeutics Inc
Study Overview
Official Title:
A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI in Breast Milk PROVIDE
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVIDE
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None