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

Study summary

No information provided.

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 that Genzyme, a Sanofi company, update the Myozyme Safety Information Packet (SIP) and conduct a study to evaluate the effectiveness of the updated version. To fulfil this requirement, a healthcare professional (HCP) survey is proposed to assess the effectiveness of the updated SIP.; ; The survey consists of two waves (Wave 1 and Wave 2), conducted before and after implementation of the updated SIP, with at least 18 months between the two waves. The survey is designed to assess whether implementation of the updated SIP has improved HCP awareness, use, perceived usefulness, readability, understanding, clinical knowledge, and behavioural implementation of key safety messages compared with the previous version of the SIP. The distribution of the SIP and HCP opinions regarding the SIP will also be evaluated.
• Study status:
  Finalised

Research institutions and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned:09/12/2014

Actual:09/12/2014

Study start date

Planned:01/05/2015

Actual:17/06/2015

Date of interim report, if expected

Planned:20/09/2015

Actual:14/09/2015

Date of final study report

Planned:08/03/2017

Actual:31/03/2017

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)