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The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome

NCT02658175 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-08-26

Study results available
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Summary

An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.

Conditions

  • Familial Chylomicronemia Syndrome
  • Lipoprotein Lipase Deficiency
  • Hyperlipoproteinemia Type 1

Interventions

DRUG

Volanesorsen

300 mg volanesorsen administered via SC injection.

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Akcea Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-23
Primary Completion
2020-01-15
Completion
2020-01-15
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02658175 on ClinicalTrials.gov