NCT02957604

Evolocumab Pregnancy Exposure Registry

Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 1 Year – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia; ASCVD; Pregnancy

Interventions

Type	Name	Description
DRUG	evolocumab	Pregnant women exposed to evolocumab. Evolocumab is not administered in this non-interventional study.

Timeline

• Start date: 2016-12-22
• Primary completion: 2020-09-02
• Completion: 2020-09-02
• First posted: 2016-11-08
• Last updated: 2020-12-17