Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444113
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IV Prospective Multicenter Open-label Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab
Status:
RECRUITING
Status Verified Date:
2024-08
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:
KATHAROS
Brief Summary:
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS The study will include lactating mothers who plan to breastfeed and initiatere-initiate ofatumumab 2-24 weeks post-partum
Detailed Description:
This is a Phase IV study in which breastfeeding mothers treated with ofatumumab and their babies are taking part for up to 1 year The study consists of a Core Part and a Safety Follow-up Part The Core Part includes a Screening period and a Sampling period During the Screening period up to 4 weeks the study doctor will assess if mothers can join the study The Sampling period during which milk samples and a blood sample will be collected will last for up to 12 weeks The Safety Follow-up Part will last for about 9 months to follow up on health and safety of mothers and their babies
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505283-11-00 | None | None | None |