NCT02211209

The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Familial Chylomicronemia Syndrome

Interventions

Type	Name	Description
DRUG	Volanesorsen
DRUG	Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-19
• Completion: 2017-03-28
• First posted: 2014-08-07
• Last updated: 2022-04-13
• Results posted: 2022-04-13

Locations

40 sites across 12 countries: United States, Brazil, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study