The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome
NCT ID: NCT02211209
Last Updated: 2022-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
67 participants
INTERVENTIONAL
2014-12-31
2017-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Volanesorsen-matching placebo administered subcutaneously once-weekly for 52 weeks.
Placebo
Volanesorsen
Volanesorsen 300 mg administered subcutaneously once-weekly for 52 weeks.
Volanesorsen
Interventions
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Volanesorsen
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
* Fasting triglycerides (TG) ≥ 750 mg/dL (8.4 mmol/L) at Screening
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Akcea Therapeutics
INDUSTRY
Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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IONIS Investigative Site
Encinitas, California, United States
IONIS Investigative Site
San Francisco, California, United States
IONIS Investigative Site
Kansas City, Kansas, United States
IONIS Investigative Site
Boston, Massachusetts, United States
IONIS Investigative Site
New York, New York, United States
IONIS Investigative Site
Oklahoma City, Oklahoma, United States
IONIS Investigative Site
Portland, Oregon, 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
Campinas, , Brazil
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
Sainte-Foy, Quebec, Canada
IONIS Investigative Site
Marseille, , France
IONIS Investigative Site
Nantes, , France
IONIS Investigative Site
Paris, , France
IONIS Investigative Site
Berlin, , Germany
IONIS Investigative Site
Dresden, , Germany
IONIS Investigative Site
Szikszó, , Hungary
IONIS Investigative Site
Safed, , Israel
IONIS Investigative Site
Milan, , Italy
IONIS Investigative Site
Palermo, , Italy
IONIS Investigative Site
Rome, , Italy
IONIS Investigative Site
Amsterdam, , Netherlands
IONIS Investigative Site
Rotterdam, , Netherlands
IONIS Investigative Site
Cape Town, , South Africa
IONIS Investigative Site
Zaragoza, Aragon, Spain
IONIS Investigative Site
A Coruña, Galicia, Spain
IONIS Investigative Site
Barcelona, , Spain
IONIS Investigative Site
Madrid, , Spain
IONIS Investigative Site
Málaga, , Spain
IONIS Investigative Site
Seville, , Spain
IONIS Investigative Site
Birmingham, , United Kingdom
IONIS Investigative Site
Manchester, , United Kingdom
IONIS Investigative Site
Manchester, , United Kingdom
IONIS Investigative Site
Peterborough, , United Kingdom
Countries
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References
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Witztum JL, Gaudet D, Freedman SD, Alexander VJ, Digenio A, Williams KR, Yang Q, Hughes SG, Geary RS, Arca M, Stroes ESG, Bergeron J, Soran H, Civeira F, Hemphill L, Tsimikas S, Blom DJ, O'Dea L, Bruckert E. Volanesorsen and Triglyceride Levels in Familial Chylomicronemia Syndrome. N Engl J Med. 2019 Aug 8;381(6):531-542. doi: 10.1056/NEJMoa1715944.
Prohaska TA, Alexander VJ, Karwatowska-Prokopczuk E, Tami J, Xia S, Witztum JL, Tsimikas S. APOC3 inhibition with volanesorsen reduces hepatic steatosis in patients with severe hypertriglyceridemia. J Clin Lipidol. 2023 May-Jun;17(3):406-411. doi: 10.1016/j.jacl.2023.04.007. Epub 2023 Apr 27.
Hegele RA, Berberich AJ, Ban MR, Wang J, Digenio A, Alexander VJ, D'Erasmo L, Arca M, Jones A, Bruckert E, Stroes ES, Bergeron J, Civeira F, Witztum JL, Gaudet D. Clinical and biochemical features of different molecular etiologies of familial chylomicronemia. J Clin Lipidol. 2018 Jul-Aug;12(4):920-927.e4. doi: 10.1016/j.jacl.2018.03.093. Epub 2018 Apr 4.
Digenio A, Dunbar RL, Alexander VJ, Hompesch M, Morrow L, Lee RG, Graham MJ, Hughes SG, Yu R, Singleton W, Baker BF, Bhanot S, Crooke RM. Antisense-Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes. Diabetes Care. 2016 Aug;39(8):1408-15. doi: 10.2337/dc16-0126. Epub 2016 Jun 6.
Other Identifiers
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2014-002421-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISIS 304801-CS6
Identifier Type: -
Identifier Source: org_study_id
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