Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy (TEG4005)

Study identification

• EU PAS number:
  EUPAS41839
• Study ID:
  41840
• Official title and acronym:
  Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy (TEG4005)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Bulgaria

  Canada

  Cyprus

  France

  Germany

  Greece

  Italy

  Portugal

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  This is a worldwide observational pregnancy surveillance program (PSP) of pregnancy exposures to TEGSEDI. The study is designed to estimate the frequency of selected pregnancy, fetal/neonatal and pregnancy complications outcomes from the TEGSEDI exposed and unexposed patients. Pregnancies will be reported voluntarily to the centrally located Pregnancy Call Center (PCC) by Healthcare Providers (HCPs), by patients and by secondary contacts. Patients will be identified from the online website, from any ongoing clinical trials, post market studies, pharmacovigilance cases or the TEGSEDI Risk Evaluation and Mitigation Strategy (REMS) Program.
• Study status:
  Planned

Research institutions and networks

Institutions

Akcea Therapeutics, Inc.

Study timelines

Date when funding contract was signed

Planned: 19/10/2019

Actual: 04/02/2020

Study start date

Planned: 15/01/2020

Date of final study report

Planned: 31/12/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Akcea Therapeutics, 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)