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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 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.

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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.

Conditions Studied

Familial Chylomicronemia Syndrome Lipoprotein Lipase Deficiency Hyperlipoproteinemia Type 1

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

FieldValue
Enrollment Target 68 participants
Start Date 2015-12-23
Est. Completion 2020-01-15
Phase Phase 3

Sponsor

Akcea Therapeutics

8 total trials

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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, categorized as Phase 3. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 65-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target. The listed sponsor is Akcea Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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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