Safety of potential paediatric patients treated by idarucizumab: a worldwide non-interventional chart review study (Pediatric NIS)

Study identification

• EU PAS number:
  EUPAS23589
• Study ID:
  27019
• Official title and acronym:
  Safety of potential paediatric patients treated by idarucizumab: a worldwide non-interventional chart review study (Pediatric NIS)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Canada

  Germany

  United Kingdom

  United States
• Study description:
  This paediatric non-interventional study is designed as a global multi-national multi-centre study based on medical charts. Sites with potential paediatric use of idarucizumab will be identified by various methods (eg. idarucizumab drug administrion surveillance program, spontaneous reporting).
• Study status:
  Cancelled

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned:03/12/2014

Study start date

Planned:31/01/2019

Date of final study report

Planned:31/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable