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

StatusActive, Not Recruiting
PhasePhase 3
Started2019-11-26
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 68 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2025-12-18
Study Status, Contacts/Locations v67
Completion date2026-12-01→2026-12-02
Study sites80→119
2025-11-13
Study Status v66
Re-verified, no change to tracked fields
2025-10-31
Study Status, Contacts/Locations v65
Study sites79→80
2025-10-03
Study Status, Document Section v64
Results first postednot stated→2025-10-21
2025-09-16
Study Status, Outcome Measures, IPDSharing, Participant Flow, Outcome Measures (Results), Adverse Events v63
Secondary endpointsdetails revised at 2 of 7 entries
Show 45 earlier versions
2025-07-25
Study Status v62
Re-verified, no change to tracked fields
2025-06-18
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v61
Secondary endpoints4 to 7 entries
Change fromFrom Baseline in 6-Minute Walk Test (6-MWT) in the Overall Population Change andFrom Baseline in 6-MWT in the Vutrisiran Monotherapy Subgroup Change fromFrom Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) in the Overall Population and Vutrisiran Monotherapy Subgroup Change from Baseline in New York Heart Association (NYHA) ClassScore in the Overall Population Change andFrom Baseline in the KCCQ-OS Score in the Vutrisiran Monotherapy Subgroup Percentage of Participants With Change in NYHA Class at Month 30 in the Overall Population Percentage of Pa [...]
2025-05-09
8 amendments v53-v60
8 re-verifications since 2024-08-09, no change to tracked fields
2024-07-11
Study Identification, Study Status, Outcome Measures v52
Primary completion dateestimated 2024-02→confirmed 2024-05-08
Completion date2026-12→2026-12-01
Secondary endpoints8 to 4 entries
Change from Baseline in 6-Minute Walk Test (6-MWT) atin Monththe 30Overall Population and Vutrisiran Monotherapy Subgroup Change from Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) atin Monththe 30Overall Population and Vutrisiran Monotherapy Subgroup All-cause Mortality in the Overall Population and Vutrisiran Monotherapy Subgroup Change from Baseline in MeanNew LeftYork VentricularHeart Association (LVNYHA) Wall Thickness by Echocardiographic Assessment at Month 30 Change from BaselineClass in Globalthe LongitudinalOverall Strain by Echocardiographic Asses [...] [...]
Primary endpoints1 to 2 entries
Composite Endpoint of All-Cause Mortality and Recurrent CV Events (CV Hospitalizations and Urgent HF Visits) in the Vutrisiran Monotherapy Subgroup Composite Endpoint of All-Cause Mortality and Recurrent Card [...] s (CV Hospitalizations and Urgent Heart Failure [HF] Visits) in the Overall Population
2024-02-12
11 amendments v41-v51
11 re-verifications since 2023-03-20, no change to tracked fields
2023-02-22
Study Status v40
Primary completion date2024-06→2024-02
Completion date2025-06→2026-12
2022-12-13
3 amendments v37-v39
3 re-verifications since 2022-10-14, no change to tracked fields
2022-09-15
Study Status, Contacts/Locations v36
Study sites80→79
2022-08-11
Study Status v35
Re-verified, no change to tracked fields
2022-07-15
Study Status, Contacts/Locations v34
Study sites90→80
2022-06-15
Study Status v33
Re-verified, no change to tracked fields
2022-05-12
Study Status, Contacts/Locations v32
Study sites102→90
2022-04-15
8 amendments v24-v31
8 re-verifications since 2021-09-15, no change to tracked fields
2021-08-17
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v23
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 600→confirmed 655
Study sites105→102
2021-07-15
Study Status, Contacts/Locations v22
Study sites104→105
2021-06-15
Study Status, Contacts/Locations v21
Study sites94→104
2021-05-14
Study Status, Contacts/Locations v20
Study sites88→94
2021-04-16
Study Status, Contacts/Locations v19
Study sites83→88
2021-03-15
Study Status, Contacts/Locations v18
Study sites63→83
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.
Trial Details
NCT Number NCT04153149
Lead Sponsor Alnylam Pharmaceuticals
Conditions Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Enrollment 655 participants
Start Date 2019-11-26
Primary Completion 2024-05-08 (estimated)
Study Completion 2026-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-12