Pregnancy Registry Protocol for Palforzia

Study identification

• EU PAS number:
  EUPAS41546
• Study ID:
  41547
• Official title and acronym:
  Pregnancy Registry Protocol for Palforzia
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Switzerland

  United Kingdom

  United States
• Study description:
  The purpose of the pregnancy registry is to collect postmarketing safety information on women exposed to Palforzia during pregnancy and on infants exposed to Palforzia in utero.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aimmune Therapeutics

Study timelines

Date when funding contract was signed

Planned: 04/03/2020

Actual: 04/03/2020

Study start date

Planned: 04/03/2020

Actual: 04/03/2020

Date of final study report

Planned: 30/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aimmune Therapeutics Inc. US and its subsidiaries

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)