Study identification

EU PAS number

EUPAS108904

Study ID

199013

Official title and acronym

Prospective Observational Study to Monitor and Assess the Safety of Amvuttra® [Vutrisiran] in a Real-World Cohort of hATTR Amyloidosis Patients

DARWIN EU® study

No

Study countries

Brazil
Bulgaria
Denmark
France
Germany
Israel
Italy
Netherlands
Portugal
Spain
Taiwan
United Kingdom
United States

Study description

This is a multinational, non-interventional, observational study based on secondary use of data and conducted over a period of 10 years to evaluate the safety of vutrisiran in hATTR amyloidosis participants exposed to vutrisiran under real-world conditions.

Study status

Ongoing
Research institutions and networks

Institutions

Multiple centres: 41 centres involved in the study

Contact details

Emily Brouwer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Alnylam
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)