Status: Planned First registered on: 20/07/2016
Last updated on: 19/09/2017
1. Study identification
EU PAS Register NumberEUPAS14255
Official titleEVALUATION 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
Study title acronymVPRIV Home infusion
Study typeOther: Survey
Brief description of the studyWhether 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Massoud
First name Toussi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/08/2016
Start date of data collection01/01/2016
Start date of data analysis03/04/2017
Date of interim report, if expected
Date of final study report30/06/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesShire Pharmaceuticals100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Massoud
First name Toussi
Address line 15-7 place des Pyramides
Address line 2 
Address line 3 
CityParis La Défense 
Postcode92088 
CountryFrance
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address mtoussi@fr.imshealth.com
Public Enquiries
Title Dr 
Last name Massoud 
First name Toussi 
Address line 15-7 place des Pyramides 
Address line 2 
Address line 3 
CityParis La Défense 
Postcode92088 
CountryFrance 
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address mtoussi@fr.imshealth.com 
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