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NCT04153149 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Transthyretin Amyloidosis (ATTR) With Cardiomyopathy, sponsored by Alnylam Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
655
Enrollment target
20
Study locations

NCT04153149: Active Phase 3 study of Transthyretin Amyloidosis (ATTR) With Cardiomyopathy, sponsored by Alnylam Pharmaceuticals.

NCT04153149 is a Phase 3 study of Transthyretin Amyloidosis (ATTR) With Cardiomyopathy that is active but no longer recruiting, run by Alnylam Pharmaceuticals. The registered enrollment target is 655 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04153149, a Phase 3 study of Transthyretin Amyloidosis (ATTR) With Cardiomyopathy, is active but no longer recruiting, sponsored by Alnylam Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
655 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) were compared between treatment groups using a modified Andersen-Gill model with a robust variance. All-cause mortality included heart transplantation and LVAD placement events along with deaths; recurrent CV events included CV hospitalizations and urgent HF visits. The number of participants with at least one CV event or all-cause mortality event have been reported here. No imputation was done for participant

Conditions Studied

Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Interventions

  • DRUG Sterile Normal Saline (0.9% NaCl)
  • DRUG Vutrisiran

Study Locations (20)

California

  • Clinical Trial Site - La Mesa
  • Clinical Trial Site - Los Angeles
  • Clinical Trial Site - Stanford

Illinois

  • Clinical Trial Site - Chicago
  • Clinical Trial Site - Evanston

Massachusetts

  • Clinical Trial Site - Boston
  • Clinical Trial Site - Boston

New York

  • Clinical Trial Site - Manhasset
  • Clinical Trial Site - New York

Pennsylvania

  • Clinical Trial Site - Allentown
  • Clinical Trial Site - Philadelphia

District of Columbia

  • Clinical Trial Site - Washington D.C.

Georgia

  • Clinical Trial Site - Gainesville

Minnesota

  • Clinical Trial Site - Rochester

Trial Details

FieldValue
Enrollment Target 655 participants
Start Date 2019-11-26
Est. Completion 2026-12-02
Phase Phase 3
Alnylam Pharmaceuticals

49 total trials

What the registry record for NCT04153149 still lists

NCT04153149 is an interventional study that assigns participants to a tested intervention. The registered 655 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).

The record links to 1 condition, with Transthyretin Amyloidosis (ATTR) With Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Sterile Normal Saline (0.9% NaCl) is the first listed.

NCT04153149 names 20 study sites across 14 states, led by California, Illinois, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04153149 about?

NCT04153149 is a clinical study titled "HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy". 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.

What is the current status of trial NCT04153149?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 655 participants. The study started on 2019-11-26. Estimated completion is 2026-12-02.

What conditions does trial NCT04153149 study?

This clinical trial studies the following conditions: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy.

What interventions are being tested in trial NCT04153149?

The interventions under investigation include: Sterile Normal Saline (0.9% NaCl) (DRUG), Vutrisiran (DRUG).

Who is sponsoring clinical trial NCT04153149?

This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04153149 being conducted?

This trial has 20 study locations across California, District of Columbia, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04153149's enrollment target sits among peer trials

655 565th of 2000 higher than 1,435 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04153149, the US trial registry maintained by the National Library of Medicine. NCT04153149 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.