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Phase 3Active, not recruitingAge-related condition

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

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)

Sponsor
Alnylam Pharmaceuticals (Industry)
Enrolment
655 enrolled
Conditions
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Interventions
Vutrisiran; Sterile Normal Saline (0.9% NaCl)
Ages
adults, older adults
Registry
NCT04153149, CTIS2023-508366-15-00

Full record on ClinicalTrials.gov

From the registry

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 outcomes

  • Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular (CV) Events (CV Hospitalizations and Urgent Heart Failure [HF] Visits) in the Overall Population
  • Composite Endpoint of All-Cause Mortality and Recurrent CV Events (CV Hospitalizations and Urgent HF Visits) in the Vutrisiran Monotherapy Subgroup

History

  1. Study completion expected

  2. Last registry update

  3. Results first posted

  4. Primary completion

  5. Started

  6. Registered

Papers citing this trial