Study identification

EU PAS number

EUPAS14255

Study ID

21000

Official title and acronym

EVALUATION OF THE EFFECTIVENESS OF RISK MINIMISATION MEASURES: A SURVEY AMONG HEALTH CARE PROFESSIONALS AND PATIENT/CAREGIVERS TO ASSESS THEIR KNOWLEDGE AND ATTITUDES ON PRESCRIBING AND HOME ADMINISTRATION CONDITIONS OF VELAGLUCERASE ALPHA (VPRIV®) IN 6 EUROPEAN COUNTRIES (VPRIV Home infusion)

DARWIN EU® study

No

Study countries

France
Germany
Italy
Netherlands
Spain
United Kingdom

Study description

Whether educational material (EM), implemented as additional risk minimisation measures (aRMMs), were effective to ensure that prescribers of velaglucerase alfa - are knowledgeable about risks related to home infusion of the product and its conditions of use, - appropriately select patients eligible for home infusion of the product, - communicate to patients and caregivers the requirements for home infusion, organisation of home infusion/preparation of infusion, safety information, infusion diary, and personalized emergency plan - give the appropriate educational materials to the patients And whether patients/caregivers appropriately understand and implement the educational material, infusion diary and emergency plan.

Study status

Planned
Research institutions and networks

Institutions

IMS Health
First published:
01/02/2024
Institution

Contact details

Toussi Massoud

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Shire Pharmaceuticals
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)