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

Planned
Research institutions and networks

Institutions

Contact details

Monik Botero

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
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)