Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-02-12 @ 12:15 PM
Study NCT ID:
NCT02957604
Status:
TERMINATED
Last Update Posted:
2020-12-17
First Post:
2016-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolocumab Pregnancy Exposure Registry
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Status:
TERMINATED
Status Verified Date:
2020-12
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:
This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy
Detailed Description:
This pregnancy registry will be conducted by University of California Research Center for the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and healthcare providers throughout North America. Participants will be enrolled on an ongoing basis through year 10 of the study and each will be followed from the time they enroll, through the 5-year postnatal follow up period for an overall study period of 15 years. Participants are recruited concurrently from callers to OTIS centers, from healthcare providers and through direct to consumer marketing efforts.
Study Oversight
Has Oversight DMC:
False
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?: