Clinical Trials Directory

Trials / Completed

CompletedNCT02658175

The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome

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)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
68 (actual)
Sponsor
Akcea Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.

Detailed description

This is a multi-center, open-label study for FCS participants rolling over from the ISIS 304801-CS6 (NCT02211209) index study, FCS participants rolling over from the ISIS 304801-CS16 (NCT02300233) index study and Treatment-naïve group. All participants were to receive volanesorsen 300 milligrams (mg) once per week for 52 weeks. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Participants had the option of continuing dosing for an additional 52 weeks (France: up to an additional 104 weeks for a total of 156 weeks) until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week (France: 26-week) post-treatment evaluation period.

Conditions

Interventions

TypeNameDescription
DRUGVolanesorsen300 mg volanesorsen administered via SC injection.

Timeline

Start date
2015-12-23
Primary completion
2020-01-15
Completion
2020-01-15
First posted
2016-01-18
Last updated
2021-08-26
Results posted
2021-08-26

Locations

34 sites across 11 countries: United States, Brazil, Canada, France, Germany, Israel, Italy, Netherlands, South Africa, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT02658175. Inclusion in this directory is not an endorsement.