Prescribing Patterns of Lipegfilgrastim (Lonquex®) in the European Union

Study identification

• EU PAS number:
  EUPAS12984
• Study ID:
  28713
• Official title and acronym:
  Prescribing Patterns of Lipegfilgrastim (Lonquex®) in the European Union
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Croatia

  Germany

  Netherlands
• Study description:
  This is a post-authorisation, multi-national, non-interventional, multicentre, retrospective DUS, to describe the pattern of lipegfilgrastim use, and specifically to quantify the extent of lipegfilgrastim off-label use in routine clinical practice. Data for approx. 500 patients of all ages who were treated with lipegfilgrastim as part of usual clinical practice will be collected at sites in several European countries. Data will be abstracted from medical charts. Data analysis in the study will be descriptive. Initially a pilot study will be conducted in order to assess the feasibility of the data collection, and to modify the protocol if needed.
• Study status:
  Ongoing

Research institutions and networks

Institutions

PRA Health Sciences

Real World Solutions, PRA Real World Solutions

France

Germany

Study timelines

Date when funding contract was signed

Actual:03/05/2016

Study start date

Planned:10/06/2019

Actual:16/12/2016

Data analysis start date

Planned:15/04/2020

Date of final study report

Planned:16/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

TEVA

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)