Eptacog beta post marketing safety surveillance using aggregated data reports from the EUHASS Registry (F7TG2206-EUHASS Registry)

Study identification

• EU PAS number:
  EUPAS105020
• Study ID:
  105021
• Official title and acronym:
  Eptacog beta post marketing safety surveillance using aggregated data reports from the EUHASS Registry (F7TG2206-EUHASS Registry)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  This Post Marketing safety Surveillance study is based on observational data collection from the European Hemophilia Safety Surveillance (EUHASS) cohort. EUHASS is a pharmacovigilance program to monitor the safety of treatments for people with inherited bleeding disorders in maintaining a database of all the haemophilia centres in Europe. EUHASS will transmit to the sponsor, LFB Biotechnologies 4 reports of adverse events issued at the end of each 3 month period and a detailed annual report.
• Study status:
  Ongoing

Research institutions and networks

Institutions

European Haemophilia Safety Surveillance System (EUHASS)

2 sites Austria, 2 sites Belgium, 6 sites France, 7 sites Germany, 10 sites Italy, 4 sites Netherlands, 5 sites Spain, 21 sites United Kingdom

Study timelines

Date when funding contract was signed

Actual:25/01/2023

Study start date

Actual:25/01/2023

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)