Study identification

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 post marketing 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 post marketing 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
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc. medinfo@amgen.com

Study contact
medinfo@amgen.com

Global Development Leader Amgen Inc.

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
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)