Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302270
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-04
Brief Title:
CFTR Modulators in Pregnancy and Postpartum
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
Official Title:
Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mothers Own Milk
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mothers own milk
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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