A Non-Interventional Prospective Study to Evaluate The Safety Of Long Term Use Of Grastofil In Patients With Severe Chronic Neutropenia Enrolled In The Severe Chronic Neutropenia International Registry (SCNIR)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35845
• EU PAS number:
  EUPAS19412
• Study ID:
  35845
• Official title and acronym:
  A Non-Interventional Prospective Study to Evaluate The Safety Of Long Term Use Of Grastofil In Patients With Severe Chronic Neutropenia Enrolled In The Severe Chronic Neutropenia International Registry (SCNIR)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Greece

  Hungary

  Ireland

  Italy

  Netherlands

  Norway

  Poland

  Portugal

  Serbia

  Spain

  Sweden

  United Kingdom
• Study description:
  Study to Evaluate The Safety Of Long Term Use Of Grastofil In Patients With Severe Chronic Neutropenia Enrolled In The Severe Chronic Neutropenia International Registry (SCNIR)Note: This study has been discontinued/cancelled based on the Grastofil (Filgrastim) updated Risk Management Plan (RMP) Version 6.0, dated 23-Jan-2020, which was approved by EMA through type-II variation (EMEA/H/C/002150/II/0030) on 11-Jun-2020.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hannover Medical School (MHH)

Study timelines

Date when funding contract was signed

Planned: 30/11/2012

Actual: 30/11/2012

Study start date

Planned: 01/02/2014

Actual: 01/02/2014

Date of final study report

Planned: 01/08/2024

Actual: 11/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Accord Healthcare S.L.U, Spain

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)