A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy (20150162)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40671
• EU PAS number:
  EUPAS15153
• Study ID:
  40671
• Official title and acronym:
  A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy (20150162)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Denmark

  France

  Greece

  Italy

  Netherlands

  Norway

  Slovakia

  South Africa

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  To evaluate outcomes of pregnancy in females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 70 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/09/2016

Actual: 05/09/2016

Study start date

Planned: 30/09/2016

Actual: 12/01/2017

Data analysis start date

Planned: 21/12/2020

Actual: 21/12/2020

Date of interim report, if expected

Planned: 30/09/2019

Date of final study report

Planned: 06/05/2021

Actual: 02/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc

Study protocol

Initial protocol

20150162_PASS Protocol_17May2016_Final_Redacted

Updated protocol

01.02.06 Public Redacted Protocol Ver 1.0 English_18Dec2018_20150162

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)