NCT02906124

Study to Evaluate the Safety of Repatha® in Pregnancy

A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Hypercholesterolaemia
• Pregnancy

Timeline

• Start date: 2017-01-12
• Primary completion: 2020-11-06
• Completion: 2020-11-06
• First posted: 2016-09-19
• Last updated: 2020-12-22

Locations

48 sites across 14 countries: Australia, Austria, Belgium, Czechia, Denmark, Greece, Italy, Netherlands, Norway, Slovakia, Spain, Sweden, Switzerland, United Kingdom