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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 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. The trial reports 20 study locations across 14 states.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 655 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2026-12-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04153149
The ClinicalTrials.gov registry entry for NCT04153149 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 655 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alnylam Pharmaceuticals, which has 49 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
ACTIVE NOT RECRUITING · Phase 3
-
APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
ACTIVE NOT RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.