Study identification

EU PAS number

EUPAS42338

Study ID

47175

Official title and acronym

VPRIV® Non-Interventional Study in Patients Previously Treated with Other Enzyme Replacement Therapies (ERTs)/Substrate Reduction Therapies (SRTs) (SHP669-405)

DARWIN EU® study

No

Study countries

Canada
Germany
Israel
Spain

Study description

The main aim of this study is to describe the safety profile of velaglucerase alfa (VPRIV) in participants with Gaucher disease type 1. Participants will be transitioning from other enzyme replacement therapies or substrate reduction therapies to VPRIV. Some participants may have already transitioned to treatment with VPRIV before this study started. In this study, data on VPRIV will be collected from the medical records of participants who already transitioned to VPRIV before this study started. Other participants will join this study when they transition to VPRIV. All participants will be followed to allow for 12 months of observation from time of transition to VPRIV. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Study status

Finalised
Research institutions and networks

Institutions

Shire
First published:
01/02/2024
Institution
Multiple centres: 4 centres are involved in the study

Contact details

Study Contact Shire

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

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

More details on funding

Shire
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable