The drug use-results survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan (PMS for idarucizumab)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48788
• EU PAS number:
  EUPAS15981
• Study ID:
  48788
• Official title and acronym:
  The drug use-results survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan (PMS for idarucizumab)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Study to evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 300 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 25/08/2016

Actual: 19/08/2016

Study start date

Planned: 27/10/2016

Actual: 25/11/2016

Data analysis start date

Planned: 01/11/2016

Actual: 25/11/2016

Date of interim report, if expected

Planned: 03/11/2021

Actual: 24/09/2021

Date of final study report

Planned: 31/07/2022

Actual: 17/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.

Regulatory

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