Safety of dabigatran etexilate (DE) for treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 2 years of age: a prospective European non-interventional cohort study based on new data collection (1160.307)

Study identification

• EU PAS number:
  EUPAS47909
• Study ID:
  47910
• Official title and acronym:
  Safety of dabigatran etexilate (DE) for treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 2 years of age: a prospective European non-interventional cohort study based on new data collection (1160.307)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Denmark

  Finland

  Germany

  Italy

  Netherlands

  Spain

  Sweden
• Study status:
  Finalised

Research institutions and networks

Institutions

C.H. van Ommen

Study timelines

Date when funding contract was signed

Actual:24/12/2021

Study start date

Planned:15/12/2022

Actual:10/08/2022

Date of final study report

Planned:20/06/2025

Actual:25/11/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim International GmbH

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)