An Observational Case Series to Describe Women Exposed to Repatha During Pregnancy and Infant Outcomes During the First Year of Life (20200408)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48529
• EU PAS number:
  EUPAS42393
• Study ID:
  48529
• Official title and acronym:
  An Observational Case Series to Describe Women Exposed to Repatha During Pregnancy and Infant Outcomes During the First Year of Life (20200408)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a Global prospective and retrospective observational case series of pregnant women exposed to Repatha during pregnancy and their infants through the first year of life who consent to provide their information to Amgen. The study aims to estimate the proportion of women who experience pregnancy and maternal complications, adverse events in the developing fetus, neonate and their infants for the first year of life. Retrospectively, data will be extracted from pre-existing postmarketing reports obtained from Amgen’s Global Safety Database for women exposed to Repatha during pregnancy and their infants between July 2015 and the approval date of this protocol. Prospectively, from approval date of this protocol through July 2025, secondary data from postmarketing reports will be analyzed for women who have been exposed to Repatha during their pregnancy and their infants.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 21/04/2021

Actual: 21/04/2021

Study start date

Planned: 17/07/2022

Actual: 17/07/2022

Data analysis start date

Planned: 30/09/2025

Date of interim report, if expected

Planned: 30/09/2022

Date of final study report

Planned: 30/09/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original evolocumab 20200408 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)