Study identification

EU PAS number

EUPAS10301

Study ID

49116

Official title and acronym

Myozyme (alglucosidase alfa) Safety Information Packet effectiveness evaluation: a health care professional survey

DARWIN EU® study

No

Study countries

France
Germany
Italy
Poland
Spain
United Kingdom

Study description

The Pharmacovigilance Risk Assessment Committee (PRAC) requested Genzyme, a Sanofi Company to further update the Myozyme Safety Information Packet (SIP) and to propose a study to evaluate the effectiveness of the updated version of the SIP. To comply with PRAC requirements, a health care professional survey that assesses the effectiveness of the updated SIP is proposed. The survey consists of two waves (wave 1 and wave 2) which are to be carried out pre- and post-implementation of the updated SIP, at least 18 months apart. The survey is intended to assess whether implementation of the updated SIP has led to increased awareness, usage, usefulness, readability, understanding, clinical knowledge and behavioural implementation of key safety messages compared with the previous version of the SIP. Distribution and opinion of HCPs about the SIP will also be evaluated.

Study status

Finalised
Research institutions and networks

Institutions

OXON Epidemiology
Spain
United Kingdom
First published:
15/03/2024
Institution Laboratory/Research/Testing facility Non-Pharmaceutical company ENCePP partner

Contact details

Nawab Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Genzyme Europe B.V., The Netherlands.
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)