Study identification

PURI

https://redirect.ema.europa.eu/resource/42816

EU PAS number

EUPAS36021

Study ID

42816

Official title and acronym

Patisiran-LNP Pregnancy Surveillance Program

DARWIN EU® study

No

Study countries

France
Germany
Italy
Netherlands
Portugal
Spain
United Kingdom
United States

Study status

Ongoing
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner
University College London United Kingdom, University of Iowa Hospitals & Clinics United States, Fondazione IRCCS Policlinico San Matteo Italy, CHU Nantes - Hôtel Dieu France, Universitaetsklinikum Muenster Germany, Hospital Universitario Clinico San Carlos Spain, Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria Portugal, Universitair Medisch Centrum Groningen (UMCG) Netherlands

Contact details

Lockwood Taylor

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Alnylam Pharmaceuticals Inc.
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)