A multinational, multi-centre, prospective, non-interventional, post-authorisation safety study in healthy donors (HDs) exposed to Nivestim (biosimilar filgrastim) for haematopoietic stem cell (HSC) mobilisation (NEST)

Study identification

• EU PAS number:
  EUPAS14052
• Study ID:
  34290
• Official title and acronym:
  A multinational, multi-centre, prospective, non-interventional, post-authorisation safety study in healthy donors (HDs) exposed to Nivestim (biosimilar filgrastim) for haematopoietic stem cell (HSC) mobilisation (NEST)
• DARWIN EU® study:
  No
• Study countries:
  Greece

  Italy

  Portugal

  Spain
• Study description:
  A non-interventional study in 100 healthy subjects due to receive or have recently (within 30 days) received Nivestim for mobilisation of HSCs in order to donate to HSC transplant patients. Healthy donors will be followed up for 5 years in order to review types and rates of adverse events of special interest, adverse drug reactions and new malignancies.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 03/09/2015

Study start date

Planned: 30/07/2016

Actual: 30/08/2016

Data analysis start date

Planned: 07/02/2023

Date of interim report, if expected

Planned: 20/06/2018

Actual: 20/06/2018

Date of final study report

Planned: 18/04/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable