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NCT02658175 · ClinicalTrials.gov registry record · Phase 3
The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
A Phase 3 study of Familial Chylomicronemia Syndrome and Lipoprotein Lipase Deficiency, sponsored by Akcea Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 68
- Enrollment target
- 20
- Study locations
NCT02658175: Completed Phase 3 study of Familial Chylomicronemia Syndrome and Lipoprotein Lipase Deficiency, sponsored by Akcea Therapeutics.
NCT02658175 is a Phase 3 study of Familial Chylomicronemia Syndrome and Lipoprotein Lipase Deficiency that has completed, run by Akcea Therapeutics. The registered enrollment target is 68 participants, roughly in line with the 65-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02658175, a Phase 3 study of Familial Chylomicronemia Syndrome and Lipoprotein Lipase Deficiency, has completed, sponsored by Akcea Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 68 participants
- Enrollment target
- 20
- Study locations
Study Summary
An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.
Primary Outcome
Baseline for treatment-naïve group was defined as the average of open-label Day 1 pre-dose assessment and the last measurement prior to open-label Day 1. Baseline for CS6-volanesorsen and CS16-volanesorsen arm groups was defined as the average of index study Day 1 pre-dose assessment and the last measurement prior index study Day 1. The values at the Month 3 analysis time point were defined as the average of the Week 12 (Day 78) and Week 13 (Day 85) fasting assessments. The Month 6 analysis time
Conditions Studied
Interventions
- DRUG Volanesorsen
Study Locations (20)
Other
- IONIS Investigative Site - São Paulo
- IONIS Investigative Site - São Paulo
- IONIS Investigative Site - Québec
- IONIS Investigative Site - Marseille
- IONIS Investigative Site - Nantes
- IONIS Investigative Site - Berlin
- IONIS Investigative Site - Cologne
- IONIS Investigative Site - Safed
California
- IONIS Investigative Site - Huntington Beach
- IONIS Investigative Site - San Francisco
Quebec
- IONIS Investigative Site - Chicoutimi
- IONIS Investigative Site - Montreal
Florida
- IONIS Investigative Site - Boca Raton
Massachusetts
- IONIS Investigative Site - Boston
Pennsylvania
- IONIS Investigative Site - Philadelphia
Texas
- IONIS Investigative Site - Houston
Virginia
- IONIS Investigative Site - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2015-12-23 |
| Est. Completion | 2020-01-15 |
| Phase | Phase 3 |
What the finished NCT02658175 record still lists
NCT02658175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, roughly in line with the 65-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target.
The record links to 3 conditions, with Familial Chylomicronemia Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Volanesorsen is the first listed.
NCT02658175 names 20 study sites across 11 states, led by Other, California, Quebec.
Frequently Asked Questions
What is clinical trial NCT02658175 about?
NCT02658175 is a clinical study titled "The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome". An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.
What is the current status of trial NCT02658175?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2015-12-23. Estimated completion is 2020-01-15.
What conditions does trial NCT02658175 study?
This clinical trial studies the following conditions: Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency, Hyperlipoproteinemia Type 1.
What interventions are being tested in trial NCT02658175?
The interventions under investigation include: Volanesorsen (DRUG).
Who is sponsoring clinical trial NCT02658175?
This trial is sponsored by Akcea Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02658175 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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