Study identification

EU PAS number

EUPAS1000000736

Study ID

1000000736

Official title and acronym

The Eplontersen Pregnancy and Lactation Outcomes Study: A Descriptive Safety Study of Pregnant and Lactating Individuals and Their Offspring Exposed to Eplontersen (EPPRO)

DARWIN EU® study

No

Study countries

Argentina
Armenia
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
China
Croatia
Czechia
Denmark
Estonia
European Union
Finland
France
Georgia
Germany
Greece
Greenland
Hungary
Iceland
India
Indonesia
Ireland
Israel
Italy
Japan
Korea, Democratic People's Republic of
Latvia
Lithuania
Luxembourg
Netherlands
New Zealand
Norway
Other
Poland
Portugal
Romania
Singapore
South Africa
Spain
Sweden
Switzerland
Türkiye
Ukraine
United Arab Emirates
United Kingdom
United Kingdom (Northern Ireland)
United States

Study description

The overall objective of this global descriptive pregnancy safety study (DPSS) is to describe the occurrence of pregnancy and maternal complications, adverse effects on the developing fetus and neonate, and adverse effects on the infant associated with exposure to eplontersen during pregnancy and/or lactation. This DPSS will analyze secondary data on cases of eplontersen-exposed pregnant and lactating individuals collected through a PRegnancy outcomes Intensive Monitoring (PRIM) enhanced pharmacovigilance (PV) approach utilizing AstraZeneca’s PV Global Safety Database (PV-Argus).

Study status

Planned
Research institutions and networks

Institutions

AstraZeneca
First published:
01/02/2024
Institution

Contact details

Myriam Alexander

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Study is sponsored by AstraZeneca
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only