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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32585
• EU PAS number:
  EUPAS27768
• Study ID:
  32585
• Official title and acronym:
  A Non-Interventional Prospective Study to Evaluate The Safety Of Long Term Use Of Accofil In Patients With Severe Chronic Neutropenia Enrolled In The Severe Chronic Neutropenia International Registry (SCNIR)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Croatia

  Cyprus

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Iceland

  Ireland

  Italy

  Latvia

  Liechtenstein

  Lithuania

  Luxembourg

  Malta

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Slovakia

  Slovenia

  Spain

  Sweden

  United Kingdom
• Study description:
  Study to Evaluate The Safety Of Long Term Use Of Accofil 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 Accofil (Filgrastim) updated Risk Management Plan (RMP) Version 4.0, dated 25-Jun-2019, which was approved by EMA through type-II variation (EMEA/H/C/003956/II/0037) on 03-Oct-2019.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hannover Medical School (MHH)

Study timelines

Date when funding contract was signed

Actual: 09/06/2015

Study start date

Planned: 31/10/2015

Actual: 31/10/2015

Date of final study report

Planned: 31/10/2025

Actual: 03/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Accord Healthcare Ltd, United Kingdom

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)