Evaluation of the Effectiveness of the Additional Risk Minimisation Measures for Hemgenix®: PASS Survey Among Physicians in European Countries

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001088
• Study ID:
  1000001088
• Official title and acronym:
  Evaluation of the Effectiveness of the Additional Risk Minimisation Measures for Hemgenix®: PASS Survey Among Physicians in European Countries
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Ireland

  Italy

  Norway

  Spain

  United Kingdom
• Study description:
  This observational, post-authorization study aims to evaluate the effectiveness of additional Risk Minimisation Measures (aRMMs) tools described in the Risk Management Plan (RMP) for Hemgenix® through a survey of physicians involved or potentially involved in Hemgenix prescription, administration and/or post-treatment monitoring.
• Study status:
  Ongoing

Research institutions and networks

Institutions

CSL Behring

Study timelines

Date when funding contract was signed

Actual:29/01/2025

Study start date

Planned:01/09/2026

Actual:01/09/2026

Date of final study report

Planned:30/06/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

CSL Behring

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)