At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 206 enrolled
Drug / intervention
Revusiran (ALN-TTRSC) +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.
A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)
In Brief
A Phase 3 clinical trial evaluating Revusiran (ALN-TTRSC) and Sterile Normal Saline (0.9% NaCl) for Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) and 5 related conditions. Completed, enrolled 206 participants across 61 sites in 9 countries.
Detailed Summary
The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has been discontinued; patients are being followed-up for safety.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC), Amyloidosis, Hereditary, Amyloid Neuropathies, Familial, Amyloid Neuropathies, Amyloidosis, Hereditary, Transthyretin-Related, Familial Transthyretin Cardiac Amyloidosis
CountriesBelgium, Canada, France, Germany, Italy, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedDec 2014
Primary CompletionMar 2017
TodayJul 2026
First PostedDec 18, 2014
Enrollment StartDec 1, 2014
Primary CompletionMar 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.5 years ago
Interventions
Revusiran (ALN-TTRSC)drug
Sterile Normal Saline (0.9% NaCl)drug