AMG 145-Observational Study to Evaluate the Safety in Pregnancy

• Research type

  Research Study

• Full title

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

• IRAS ID

  209876

• Contact name

  Handrean Soran

• Contact email

  hsoran@aol.com

• Sponsor organisation

  Amgen Ltd

• Duration of Study in the UK

  9 years, 4 months, 30 days

• Research summary

  In light of the limited data available on use of Repatha in association with pregnancy and/or lactation, this study is being conducted in response to a request by the EMA to provide data on outcomes of pregnancy in women (and their infants to the age of 12 months) exposed to Repatha prior to or during pregnancy and/or breast-feeding. This multinational observational study is expected to enrol female FH patients, identified in collaboration with specialist physicians and patient groups: Females with FH exposed to Repatha during pregnancy and/or breast-feeding will form the exposed cohort, and females with FH unexposed to Repatha during pregnancy and/or breast-feeding will form the internal comparator group. Although no formal comparison of exposed/unexposed subjects is planned, capturing outcomes of pregnancy in a rare population unexposed to Repatha will provide some contemporary point of reference against which to consider outcomes in exposed pregnancies.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  17/NW/0094

• Date of REC Opinion

  10 Mar 2017

• REC opinion

  Further Information Favourable Opinion