Use of Erythropoiesis Stimulating Agents (ESAs) in Patients Receiving Myelosuppressive Chemotherapy in Europe and the UK (20190404)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50771
• EU PAS number:
  EUPAS49757
• Study ID:
  50771
• Official title and acronym:
  Use of Erythropoiesis Stimulating Agents (ESAs) in Patients Receiving Myelosuppressive Chemotherapy in Europe and the UK (20190404)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Spain

  United Kingdom
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 06/01/2020

Study start date

Planned: 20/01/2023

Actual: 27/01/2023

Data analysis start date

Planned: 30/09/2024

Actual: 30/09/2024

Date of final study report

Planned: 30/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Amendment darbepoetin alfa 20190404 4 redacted

Updated protocol

Protocol-Published Amendment darbepoetin alfa 20190404 6.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)