Healthcare Professional (HCP) Survey to Assess the Effectiveness of the Additional Risk Minimization Measures (aRMM) for Casgevy® (exagamglogene autotemcel)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000704
• Study ID:
  1000000704
• Official title and acronym:
  Healthcare Professional (HCP) Survey to Assess the Effectiveness of the Additional Risk Minimization Measures (aRMM) for Casgevy® (exagamglogene autotemcel)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Spain
• Study description:
  This multi-national, observational cross-sectional design aims to measure the effectiveness of the aRMM for Casgevy by assessing HCPs’ knowledge and behaviour in relation to the educational materials. It will specifically assess the HCPs’ understanding of the important safety information in the Guide for HCPs and their awareness and utilization of the aRMM tools. ; This web-based survey will target all HCPs who have counseled patients regarding Casgevy as a treatment option across all ATCs in all EU countries where Casgevy is launched approximately 18 months after first drug availability has been achieved in any EU country. The same survey will be used for all participating countries to ensure consistency in testing the target population. ;
• Study status:
  Ongoing

Research institutions and networks

Institutions

Vertex Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned:11/03/2024

Actual:11/03/2024

Study start date

Planned:30/09/2026

Actual:01/09/2026

Data analysis start date

Planned:01/01/2027

Date of interim report, if expected

Planned:30/04/2027

Date of final study report

Planned:31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Vertex Pharmaceuticals Incorporated

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)