Fabrazyme (agalsidase beta) home infusion educational materials effectiveness evaluation: a survey for healthcare providers and patients/caregivers (Fabrazyme Home Infusion Ed Mat Survey)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35382
• EU PAS number:
  EUPAS23142
• Study ID:
  35382
• Official title and acronym:
  Fabrazyme (agalsidase beta) home infusion educational materials effectiveness evaluation: a survey for healthcare providers and patients/caregivers (Fabrazyme Home Infusion Ed Mat Survey)
• DARWIN EU® study:
  No
• Study countries:
  Finland

  France

  Italy

  Norway

  United Kingdom
• Study description:
  The objective of this study is to assess the effectiveness of the agalsidase beta (Fabrazyme®) home infusion educational materials from both the healthcare provider (HCP) and the patient perspectives with regard to: distribution, understanding, usage, implementation of the logbook and opinions of the material.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned: 13/12/2017

Actual: 13/12/2017

Study start date

Planned: 01/12/2018

Actual: 01/11/2018

Date of final study report

Planned: 01/08/2019

Actual: 06/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi Genzyme

Study protocol

Initial protocol

rdctEUPASS-AGALSC08994 Protocol-Final PDFA version-29APR2020

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)

Other study registration identification numbers and links

AGALSC08994