Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628687
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
SKYCLARYS Omaveloxolone Pregnancy and Lactation Surveillance Program
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Post-Marketing Observational Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus Neonate and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy andor Lactation
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The primary objective of the study is to assess the risks associated with pregnancy and maternal complications in women with Friedreichs Ataxia FA exposed to omaveloxolone during pregnancy andor lactation The secondary objective is to assess the adverse effects on the developing fetus neonate and infant in women exposed to omaveloxolone during pregnancy andor lactation
Detailed Description:
None
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