An Open-Label Extension Study to Assess the Safety and Efficacy of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518343-38-00

Acronym

ALN-TTRSC02-007

Enrollment

208

Registered

2025-01-28

Start date

2025-02-12

Completion date

Unknown

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

Brief summary

Frequency of adverse events

Detailed description

Change from baseline in KCCQ-OS score, Change from baseline in NYHA class, Change from baseline in cardiac biomarkers (NT-proBNP and troponin I), All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits), Change from baseline in serum TTR level

Interventions

DRUGAmvuttra 25 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events	—

Secondary

Measure	Time frame
Change from baseline in KCCQ-OS score, Change from baseline in NYHA class, Change from baseline in cardiac biomarkers (NT-proBNP and troponin I), All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits), Change from baseline in serum TTR level	—

Countries

Austria, Belgium, Czechia, Denmark, France, Italy, Netherlands, Norway, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026