Effectiveness of the Nplate Additional Risk Minimisation Materials Implemented in Australia (20210176)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49211
• EU PAS number:
  EUPAS46340
• Study ID:
  49211
• Official title and acronym:
  Effectiveness of the Nplate Additional Risk Minimisation Materials Implemented in Australia (20210176)
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 01/04/2022

Actual: 01/04/2022

Study start date

Planned: 01/04/2022

Actual: 06/04/2022

Data analysis start date

Planned: 01/06/2022

Actual: 01/06/2022

Date of final study report

Planned: 30/11/2022

Actual: 25/01/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original romiplostim 20210176

Regulatory

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