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The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
NCT02658175 · View on ClinicalTrials.gov ↗
Study Summary
An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02658175
The ClinicalTrials.gov registry entry for NCT02658175 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akcea Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02658175 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02658175?
The interventions under investigation include: Volanesorsen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02658175?
This trial is sponsored by Akcea Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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