At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 211 enrolled
Drug / intervention
Patisirandrug
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 Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients With Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Patisiran Clinical Study
In Brief
A Phase 3 clinical trial evaluating Patisiran for Amyloidosis. Completed, enrolled 211 participants across 56 sites in 21 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyloidosis
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Cyprus, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedJul 2015
Primary CompletionNov 2022
TodayJul 2026
First PostedJul 29, 2015
Enrollment StartJul 16, 2015
Primary CompletionNov 23, 2022
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 10.9 years ago
Interventions
Patisirandrug
Patisiran was administered IV.