The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
Completed · Phase 3
Conditions studied: Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency, Hyperlipoproteinemia Type 1
In brief
An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.
Key facts
- Study ID
- NCT02658175
- Run by
- Akcea Therapeutics
- People needed
- 68
- Starts
- 2015-12-23
- Expected to finish
- 2020-01-15
- Last updated by the study team
- 2021-08-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must give written informed consent to participate in the study (signed and dated) and any authorization required by law.
- Able and willing to participate in a 65-week study.
- Group 1 and 2:
- Satisfactory completion of ISIS 304801-CS6 (NCT02211209) or ISIS 304801-CS16 (NCT02300233) index studies with an acceptable safety profile, per Sponsor and Investigator judgment.
- Group 3:
- Participants who did not participate in the CS6 or CS16 index studies and meet additional inclusion criteria of FCS may enroll in the study.
- History of chylomicronemia.
- A diagnosis of FCS (Type 1 Hyperlipoproteinemia.)
- Fasting triglycerides greater than or equal to (≥)750 milligrams per deciliter [mg/dL] (8.4 millimoles per liter [mmol/L]) at Screening.
You may not qualify if…
- Unwilling to comply with lifestyle requirements for the duration of the study.
- Group 1 and 2:
- Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study.
- Group 3:
- Diabetes mellitus if newly diagnosed or if hemoglobin A1c (HbA1c)≥ 9.0%.
- 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.
- 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 — Huntington Beach, California, United States
- IONIS Investigative Site — San Francisco, California, United States
- IONIS Investigative Site — Boca Raton, Florida, United States
- IONIS Investigative Site — Boston, Massachusetts, 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 — 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 — Montreal, Quebec, Canada
- IONIS Investigative Site — Québec, Canada
- IONIS Investigative Site — Paris, Cedex 13, France
- IONIS Investigative Site — Marseille, France
- IONIS Investigative Site — Nantes, France
- IONIS Investigative Site — Berlin, Germany
- IONIS Investigative Site — Cologne, Germany
- IONIS Investigative Site — Safed, Israel
- IONIS Investigative Site — Palermo, Italy
- IONIS Investigative Site — Roma, Italy
- IONIS Investigative Site — Rome, Italy
- IONIS Investigative Site — Amsterdam-Zuidoost, Netherlands
- IONIS Investigative Site — Cape Town, South Africa
Full record on ClinicalTrials.gov
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