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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04153149

Public ClinicalTrials.gov record NCT04153149. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04153149
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alnylam Pharmaceuticals
Industry
Enrollment
655 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 26, 2019 (Actual)
Primary completion
May 8, 2024 (Actual)
Completion
Dec 2, 2026 (Estimated)
Last update posted
Jan 12, 2026

2019 – 2026

United States locations

U.S. sites
17
U.S. states
11
U.S. cities
16
Facility City State ZIP Site status
Clinical Trial Site La Mesa California 91942 —
Clinical Trial Site Los Angeles California 90033 —
Clinical Trial Site Stanford California 94305 —
Clinical Trial Site Washington D.C. District of Columbia 20010 —
Clinical Trial Site Gainesville Georgia 30501 —
Clinical Trial Site Chicago Illinois 60637 —
Clinical Trial Site Evanston Illinois 60201 —
Clinical Trial Site Boston Massachusetts 02115 —
Clinical Trial Site Boston Massachusetts 02118 —
Clinical Trial Site Rochester Minnesota 55902 —
Clinical Trial Site Manhasset New York 11030 —
Clinical Trial Site New York New York 10032 —
Clinical Trial Site Durham North Carolina 27710 —
Clinical Trial Site Cleveland Ohio 44195 —
Clinical Trial Site Allentown Pennsylvania 18103 —
Clinical Trial Site Philadelphia Pennsylvania 19104 —
Clinical Trial Site Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04153149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 12, 2026 · Synced Oct 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04153149 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →