Eptacog Beta post marketing safety surveillance using the PedNet registry (F7TG2207 – PedNet Registry)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105708
• EU PAS number:
  EUPAS105707
• Study ID:
  105708
• Official title and acronym:
  Eptacog Beta post marketing safety surveillance using the PedNet registry (F7TG2207 – PedNet Registry)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  This Post Marketing Surveillance study is based on observational data collection from the Pediatric Network Hemophilia Registry (PedNet) cohort. PedNet (Pediatric Network on haemophilia management) is a collaborative platform for (pediatric) physicians treating children with haemophilia. The PedNet Haemophilia Registry is a database containing observational data of children with haemophilia A and B. PedNet will transmitt to the sponsor, LFB Biotechnologies, annuals reports of adverse events.
• Study status:
  Ongoing

Research institution and networks

Institutions

PedNet Haemophilia Research Foundation

Netherlands

1 site Belgium, 3 sites France, 2 sites Germany, 1 site Italy, 3 sites Spain, 4 sites UK, 2 sites Netherlands

Study timelines

Date when funding contract was signed

Actual: 01/03/2023

Study start date

Actual: 01/01/2023

Date of final study report

Planned: 30/06/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

LFB Biotechnologies

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)