At a glance
ClinicalIndex Comparison RecordPhase 3Active· 655 enrolled
Drug / intervention
Vutrisiran +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Vutrisiran and Sterile Normal Saline (0.9% NaCl) for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy. Active but no longer recruiting, targeting 655 participants across 119 sites in 32 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Belgium, Canada, Croatia, Czechia, Denmark, France, Germany, Hungary, Ireland, Israel, Japan, Latvia, Lebanon, Lithuania, Malaysia, Moldova, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
20202021202220232024202520262027
First PostedNov 2019
Enrollment StartNov 2019
Primary CompletionMay 2024
TodayJul 2026
Study CompletionDec 2026
First PostedNov 6, 2019
Enrollment StartNov 26, 2019
Primary CompletionMay 8, 2024
Study CompletionDec 2, 2026
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 6.7 years ago
Interventions
Vutrisirandrug
Vutrisiran will be administered by SC injection.
Sterile Normal Saline (0.9% NaCl)drug
Sterile normal saline (0.9% NaCl) will be administered by SC injection.