Study to Evaluate the Safety of Repatha® in Pregnancy

Amgen

Status: Terminated

Conditions: Hypercholesterolaemia; Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT02906124

20150162

Details and patient eligibility

About

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

Full 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

Enrollment: 4 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females diagnosed with Familial hypercholesterolaemia (FH).
• Confirmed pregnancy during the study observation period.
• Pregnancies identified retrospectively but within the study period will be included
• Multiple pregnancies, occurring in the same woman within the study period, will all be included (as separate pregnancies)
• Provided informed consent to follow-up in this study, for subject and their infant(s) born during the study observation period

Exclusion criteria

There are no exclusion criteria

Trial design

4 participants in 2 patient groups

Repatha® exposed

Description:

Females with familial hypercholesterolaemia (FH) exposed to Repatha® in the 15 weeks prior to or during pregnancy or during breastfeeding

Non exposed to Repatha®

Description:

Pregnant females with familial hypercholesterolaemia (FH) not exposed to Repatha® and enrolled into this study, overall and stratified by lipid lowering therapy use