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Enrolling by invitationPhase 3

Continued vutrisiran treatment for adults with heart disease from transthyretin amyloidosis

Studies vutrisiran in adults with transthyretin amyloidosis and heart muscle disease, continuing or switching treatment.

Key facts

Who runs it
Alnylam Pharmaceuticals
Where
Prague, CzechiaSee the siteAlso in 16 other countries, 72 sites
Registry title
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Status
Enrolling by invitation
Phase
Phase 3
People taking part
700 people, planned
Started
3 Dec 2024
Expected to end
31 Mar 2028
Type of study
Interventional
Treatments tested
  • Vutrisiran
Record updated
21 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with transthyretin amyloidosis with heart muscle disease who took part in earlier patisiran or vutrisiran studies.

Age
18 years or older
Sex
All sexes can join
Disease stage
Transthyretin amyloidosis (ATTR) with cardiomyopathy
Earlier treatment
Must be taking part in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014, or have completed the 24-month OLE Period of the vutrisiran parent study ALN-TTRSC02-003

Main reasons for not taking part

  • Stopped study drug for good during the parent studies ALN-TTR02-011, ALN-TTR02-014 or ALN-TTRSC02-003
  • Plans to join another study of an investigational device or drug during this study
  • Has other medical conditions that the investigator thinks would interfere with following the study or understanding the data

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Patients who are participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003

Who cannot take part

  • Has permanently discontinued study drug administration while participating in the parent studies, ALN-TTR02-011, ALN-TTR02-014, or ALN-TTRSC02-003
  • Future or current participation in another investigational device or drug study, scheduled to occur during this study
  • Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation

Where in Czechia

Also in 16 other countries, 72 sites

  • PragueHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

The purpose of this study is to obtain safety, efficacy, and pharmacodynamic data on the use of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy who continued on extended use of vutrisiran, or switched from patisiran.

The group in the trial

  • Vutrisiran 25 mgTreatment being tested

    Participants will receive vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M).

    Treatment: Vutrisiran

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-Label Extension Study to Assess the Safety and Efficacy of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
Plain-language title
Continued vutrisiran treatment for adults with heart disease from transthyretin amyloidosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 October 2026