Status:
COMPLETED
The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Collaborating Sponsors:
Akcea Therapeutics
Conditions:
Familial Chylomicronemia Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome
Eligibility Criteria
Inclusion
- History of chylomicronemia
- A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
- Fasting triglycerides (TG) ≥ 750 mg/dL (8.4 mmol/L) at Screening
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2017
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT02211209
Start Date
December 1 2014
End Date
March 28 2017
Last Update
April 13 2022
Active Locations (40)
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1
IONIS Investigative Site
Encinitas, California, United States, 92024
2
IONIS Investigative Site
San Francisco, California, United States, 94143
3
IONIS Investigative Site
Kansas City, Kansas, United States, 66214
4
IONIS Investigative Site
Boston, Massachusetts, United States, 02114