At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
Placebo +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.
APOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
In Brief
A Phase 3 clinical trial evaluating Placebo and Patisiran for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy. Completed, enrolled 360 participants across 90 sites in 22 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Chile, Czechia, Denmark, France, Hong Kong, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, South Korea, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartSep 2019
Primary CompletionJun 2022
Study CompletionDec 2025
TodayJul 2026
First PostedJun 25, 2019
Enrollment StartSep 4, 2019
Primary CompletionJun 20, 2022
Study CompletionDec 24, 2025
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.0 years ago
Interventions
Placebodrug
Normal saline (0.9% NaCl) matching volume of patisiran doses will be administered intravenously.
Patisirandrug
Patisiran will be administered by intravenous (IV) infusion.