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HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

NCT04153149 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2026-01-12

Study results available
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Summary

This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.

Conditions

  • Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Interventions

DRUG

Vutrisiran

Vutrisiran will be administered by SC injection.

DRUG

Sterile Normal Saline (0.9% NaCl)

Sterile normal saline (0.9% NaCl) will be administered by SC injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2024-05-08
Completion
2026-12-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Japan
  • Latvia
  • Lebanon
  • Lithuania
  • Malaysia
  • Moldova
  • Netherlands
  • Norway
  • Peru
  • Poland
  • Portugal
  • Saudi Arabia
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153149 on ClinicalTrials.gov