At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 135 enrolled
Drug / intervention
Inotersendrug
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.
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)
In Brief
A Phase 3 clinical trial evaluating Inotersen for FAP and 4 related conditions. Completed, enrolled 135 participants across 22 sites in 9 countries.
Detailed Summary
This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in patients with Familial Amyloid Polyneuropathy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFAP, Familial Amyloid Polyneuropathy, TTR, Transthyretin, Amyloidosis
CountriesArgentina, Brazil, France, Germany, Italy, Portugal, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJun 2014
Primary CompletionSep 2020
Study CompletionJan 2021
TodayJul 2026
First PostedJun 26, 2014
Enrollment StartJun 26, 2014
Primary CompletionSep 11, 2020
Study CompletionJan 7, 2021
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 12.0 years ago
Interventions
Inotersendrug
Inotersen SC