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

• PURI:
  https://redirect.ema.europa.eu/resource/47910
• 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:
  Belgium

  Czechia

  Finland

  France

  Germany

  Italy

  Poland

  Spain

  Sweden
• Study status:
  Planned

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

Date of final study report

Planned: 20/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim International GmbH

Study protocol

Updated protocol

1160.307_NIS-protocol_v.3.0_signed_redacted.pdf

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)