At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 67 enrolled
Drug / intervention
Volanesorsen +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 Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
In Brief
A Phase 3 clinical trial evaluating Volanesorsen and Placebo for Familial Chylomicronemia Syndrome. Completed, enrolled 67 participants across 40 sites in 12 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Chylomicronemia Syndrome
CountriesBrazil, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, United Kingdom, United States
CollaboratorsAkcea Therapeutics
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartDec 2014
Primary CompletionDec 2016
Study CompletionMar 2017
TodayJul 2026
First PostedAug 7, 2014
Enrollment StartDec 1, 2014
Primary CompletionDec 19, 2016
Study CompletionMar 28, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.9 years ago
Interventions
Volanesorsendrug
Placebodrug