Tafamidis Pregnancy Surveillance Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47046
• EU PAS number:
  EUPAS37119
• Study ID:
  47046
• Official title and acronym:
  Tafamidis Pregnancy Surveillance Study
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Germany

  Japan

  Portugal

  Spain

  United Kingdom

  United States
• Study description:
  This descriptive non-interventional study of women diagnosed with ATTR exposed to tafamidis during or within 1 month prior to pregnancy is intended to assess the risks of pregnancy outcomes and adverse effects on the developing fetus, neonate and infant.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 28/04/2020

Actual: 28/04/2020

Study start date

Planned: 30/04/2020

Actual: 22/06/2020

Date of interim report, if expected

Planned: 30/04/2021

Date of final study report

Planned: 31/12/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only