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

Completed · Phase 3 · Has a placebo group

Conditions studied: Familial Chylomicronemia Syndrome

In brief

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

Key facts

Study ID

NCT02211209

Run by

Ionis Pharmaceuticals, Inc.

People needed

67

Starts

2014-12-01

Expected to finish

2017-03-28

Last updated by the study team

2022-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of chylomicronemia
• A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
• Fasting triglycerides (TG) ≥ 750 mg/dL (8.4 mmol/L) at Screening

You may not qualify if…

• Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
• Other types of severe hypertriglyceridemia
• Active pancreatitis within 4 weeks of screening
• Acute Coronary Syndrome within 6 months of screening
• Major surgery within 3 months of screening
• Treatment with Glybera therapy within 2 years of screening
• Previous treatment with IONIS-APOCIIIRx
• Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study

Where it is running

• IONIS Investigative Site — Encinitas, California, United States
• IONIS Investigative Site — San Francisco, California, United States
• IONIS Investigative Site — Kansas City, Kansas, United States
• IONIS Investigative Site — Boston, Massachusetts, United States
• IONIS Investigative Site — New York, New York, United States
• IONIS Investigative Site — Oklahoma City, Oklahoma, United States
• IONIS Investigative Site — Portland, Oregon, United States
• IONIS Investigative Site — Philadelphia, Pennsylvania, United States
• IONIS Investigative Site — Houston, Texas, United States
• IONIS Investigative Site — Norfolk, Virginia, United States
• IONIS Investigative Site — Seattle, Washington, United States
• IONIS Investigative Site — Campinas, Brazil
• IONIS Investigative Site — São Paulo, Brazil
• IONIS Investigative Site — São Paulo, Brazil
• IONIS Investigative Site — Vancouver, British Columbia, Canada
• IONIS Investigative Site — Chicoutimi, Quebec, Canada
• IONIS Investigative Site — Sainte-Foy, Quebec, Canada
• IONIS Investigative Site — Marseille, France
• IONIS Investigative Site — Nantes, France
• IONIS Investigative Site — Paris, France
• IONIS Investigative Site — Berlin, Germany
• IONIS Investigative Site — Dresden, Germany
• IONIS Investigative Site — Szikszó, Hungary
• IONIS Investigative Site — Safed, Israel
• IONIS Investigative Site — Milan, Italy

Full record on ClinicalTrials.gov

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