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

• Status: Completed
• Trial end date: 2017-03-28
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Collaborator: Akcea Therapeutics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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