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

This study has been completed.
Sponsor:
Collaborator:
Akcea Therapeutics
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02211209
First received: August 5, 2014
Last updated: May 1, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in patients with Familial Chylomicronemia Syndrome

Condition Intervention Phase
Familial Chylomicronemia Syndrome Drug: volanesorsen Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

Resource links provided by NLM:


Further study details as provided by Ionis Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Efficacy of ISIS-APOCIIIRx as measured by the percent change in fasting triglycerides from baseline [ Time Frame: 13 Weeks ]

Enrollment: 67
Study Start Date: August 2014
Study Completion Date: March 27, 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: volanesorsen
300 mg volanesorsen administered subcutaneously once-weekly for 52 weeks
Drug: volanesorsen
Other Names:
  • ISIS 304801
  • ApoC-III
  • Approach
  • IONIS-APOCIIIRx
Placebo Comparator: Placebo
Placebo administered subcutaneously once-weekly for 52 weeks
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of chylomicronemia
  • A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
  • Fasting triglycerides ≥ 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 patient participating in or completing the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02211209

  Show 42 Study Locations
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Akcea Therapeutics
  More Information

Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02211209     History of Changes
Other Study ID Numbers: ISIS 304801-CS6
Study First Received: August 5, 2014
Last Updated: May 1, 2017

Additional relevant MeSH terms:
Syndrome
Hyperlipoproteinemia Type I
Disease
Pathologic Processes
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 22, 2017