Study to Evaluate the Safety of Repatha® in Pregnancy

Status Terminated

Clinical Trial Summary

To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months

Clinical Trial Description

Women diagnosed with familial hypercholesterolaemia (FH), treated at centres in Europe, South Africa and Australia, with pregnancy confirmed during the study observation period and who provide informed consent to participate in the study. Exposed subjects are women who received Repatha® during pregnancy and/or breastfeeding; unexposed subjects are women who have not received Repatha® during pregnancy and/or breast-feeding. In infants, exposure may occur in utero and/or via breast milk, within 15 weeks following the date of Repatha® dosing in the mother ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02906124
Study type	Observational
Source	Amgen
Contact
Status	Terminated
Phase
Start date	January 12, 2017
Completion date	November 6, 2020

View Details

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