A Retrospective Chart-Review Study to Evaluate the Safety, Effectiveness and Dosing of Dalteparin for Treatment of Venous Thromboembolism (VTE) in Neonates

Study identification

• EU PAS number:
  EUPAS42367
• Study ID:
  50681
• Official title and acronym:
  A Retrospective Chart-Review Study to Evaluate the Safety, Effectiveness and Dosing of Dalteparin for Treatment of Venous Thromboembolism (VTE) in Neonates
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This non-interventional study (NIS) utilizing secondary (i.e., existing) data from routine clinical care is designed to characterize the safety, effectiveness and dosing of dalteparin in neonates treated for VTE. This NIS is designated as a Post-Authorization Safety Study and is a Post-Marketing Requirement to the FDA
• Study status:
  Finalised

Research institutions and networks

Institutions

Kantar Health

Multiple centres: 7 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 30/07/2021

Actual: 17/12/2019

Study start date

Planned: 01/01/2021

Actual: 06/01/2022

Data analysis start date

Planned: 03/05/2022

Actual: 17/05/2022

Date of final study report

Planned: 31/12/2022

Actual: 15/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Regulatory

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

Other study registration identification numbers and links

A6301097