HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
In brief
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.
Key facts
- Study ID
- NCT04153149
- Run by
- Alnylam Pharmaceuticals
- People needed
- 655
- Starts
- 2019-11-26
- Expected to finish
- 2026-12-02
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has a documented diagnosis of transthyretin (ATTR) amyloidosis with cardiomyopathy, classified as either hereditary ATTR (hATTR) amyloidosis with cardiomyopathy or wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy meeting pre-specified diagnostic criteria
- Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF OR clinical evidence of HF
You may not qualify if…
- Has known primary amyloidosis or leptomeningeal amyloidosis
- Has New York Heart Association (NYHA) Class IV heart failure
- Has NYHA Class III heart failure AND is at high risk based on pre-specified criteria
- Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit
- Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m\^2
- Has received prior TTR-lowering treatment
- Has other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease
Where it is running
- Clinical Trial Site — Los Angeles, California, United States
- Clinical Trial Site — Stanford, California, United States
- Clinical Trial Site — Washington D.C., District of Columbia, United States
- Clinical Trial Site — Gainesville, Georgia, United States
- Clinical Trial Site — Chicago, Illinois, United States
- Clinical Trial Site — Evanston, Illinois, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Rochester, Minnesota, United States
- Clinical Trial Site — Manhasset, New York, United States
- Clinical Trial Site — New York, New York, United States
- Clinical Trial Site — Durham, North Carolina, United States
- Clinical Trial Site — Cleveland, Ohio, United States
- Clinical Trial Site — Allentown, Pennsylvania, United States
- Clinical Trial Site — Philadelphia, Pennsylvania, United States
- Clinical Trial Site — Houston, Texas, United States
- Clinical Trial Site — Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
- Clinical Trial Site — Buenos Aires, Pilar, Argentina
- Clinical Trial Site — Buenos Aires, Argentina
- Clinical Trial Site — Buenos Aires, Argentina
- Clinical Trial Site — Darlinghurst, New South Wales, Australia
- Clinical Trial Site — Northmead, New South Wales, Australia
- Clinical Trial Site — Woolloongabba, Queensland, Australia
- Clinical Trial Site — Adelaide, South Australia, Australia
- Clinical Trial Site — La Mesa, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.