Patisiran-LNP Pregnancy Surveillance Program

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 States
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Hospital Clinico San Carlos

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

Study timelines

Date when funding contract was signed

Actual: 12/10/2018

Study start date

Planned: 01/01/2021

Actual: 01/08/2020

Date of final study report

Planned: 12/10/2030

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)

Other study registration identification numbers and links

ALN-TTR02-010, FDA postmarketing requirement PMR 3425-1