At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 68 enrolled
Drug / intervention
Volanesorsendrug
Likely dose
Volanesorsen 300 mgfrom 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.
ISIS 304801-CS7 The APPROACH Open Label Study Volanesorsen (ISIS 304801) An Open-Label Study of Volanesorsen Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
In Brief
A Phase 3 clinical trial evaluating Volanesorsen for Familial Chylomicronemia Syndrome and 2 related conditions. Completed, enrolled 68 participants across 34 sites in 11 countries.
Detailed Summary
An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency, Hyperlipoproteinemia Type 1
CountriesBrazil, Canada, France, Germany, Israel, Italy, Netherlands, South Africa, Spain, United Kingdom, United States
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedJan 2016
Primary CompletionJan 2020
TodayJul 2026
First PostedJan 18, 2016
Enrollment StartDec 23, 2015
Primary CompletionJan 15, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.5 years ago
Interventions
Volanesorsendrug
300 mg volanesorsen administered via SC injection.