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

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ClinicalTrials.gov Identifier: NCT02211209
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Akcea Therapeutics
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Familial Chylomicronemia Syndrome Drug: volanesorsen Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Actual Study Start Date : December 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 27, 2017

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Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211209


  Show 42 Study Locations
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Akcea Therapeutics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02211209     History of Changes
Other Study ID Numbers: ISIS 304801-CS6
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

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