HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
ClinicalTrials.gov ID: NCT04153149
Sponsor: Alnylam Pharmaceuticals
Information provided by: Alnylam Pharmaceuticals (Responsible Party)
Last Update Posted: 2023-09-07
Brief 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 patients with ATTR amyloidosis with cardiomyopathy.
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)
Intervention / Treatment:
- Drug: Vutrisiran
- Drug: Sterile Normal Saline (0.9% NaCl)
| Category | Value |
|---|---|
| Study Start (Actual) | 2019-11-26 |
| Primary Completion (Estimated) |
2024-02
|
| Study Completion (Estimated) | 2026-12 |
| Enrollment (Actual) | 655 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
ALN-TTRSC02-003 |