Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594068
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Prospective Registry Investigating Maternal Infant and Lactation Outcomes in Anifrolumab Users
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PRIMULA Lac Prospective Registry Investigating Maternal Infant and Lactation Outcomes in Anifrolumab Users The AstraZeneca Lactation Study for Anifrolumab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMULA Lac
Brief Summary:
Prospective Registry Investigating Maternal Infant and Lactation Outcomes in Anifrolumab Users PRIMULA Lac is a Post Marketing Requirements PMR study designed to fulfill the FDA post-marketing requirements The study will collect data about the presence of anifrolumab in human breast milk and serum maternal and infant among lactating individuals who receive anifrolumab therapeutically
Detailed Description:
PRIMULA Lac is an open-label open enrollment post marketing study to assess concentrations of anifrolumab in breast milk and serum in lactating individuals who are receiving anifrolumab therapeutically and to evaluate exposure on the breastfed infant Milk collection will occur at a series of 14 timepoints Maternal serum will be collected Day 1 pre-dose and 0-4 hours post-dose Day 12 and approximately Day 29 immediately preceding subsequent dose Infant serum will be collected on approximately Day 30 following the next dose and after 24 hours of breast feeding Maternal and infant adverse events AEs will be actively collected for the duration of the study Total duration of participation for each participant will be approximately 1 month The objective of this lactation study is to assess presence of anifrolumab in breast milk and serum maternal and infant among lactating individuals who receive anifrolumab therapeutically and to evaluate exposure in the breastfed infant This is a Post Marketing Requirements PMR study designed to fulfill the FDA post-marketing requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None