A non-randomized, prospective, multicenter, observational, post-authorization study to assess the efficacy of Pelgraz® (pegfilgrastim) in the primary prevention of febrile neutropenia in patients receiving high risk myelosuppressive chemotherapy (ACCPEG1)

Study identification

• EU PAS number:
  EUPAS31084
• Study ID:
  47840
• Official title and acronym:
  A non-randomized, prospective, multicenter, observational, post-authorization study to assess the efficacy of Pelgraz® (pegfilgrastim) in the primary prevention of febrile neutropenia in patients receiving high risk myelosuppressive chemotherapy (ACCPEG1)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy
• Study description:
  The study is planned as an observational, prospective, study with the objective to assess the efficacy of Pelgraz® in patients receiving myelosuppressive chemotherapy (CTH) for the primary prevention of febrile neutropenia (FN). Additional aim is the assessment of the safety and the utilization pattern of Pelgraz® in patients receiving myelosuppressive CTH. The study will be conducted in multiple European clinical practices. The selection of study sites will be based on the experience of the site in conducting clinical trials and administering myelosuppressive CTH.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Europharma

Study timelines

Date when funding contract was signed

Planned: 15/01/2019

Actual: 15/01/2019

Study start date

Planned: 03/02/2020

Actual: 11/02/2020

Date of final study report

Planned: 31/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Accord Healthcare Limited

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable