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

NCT02211209 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2022-04-13

Study results available
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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

Conditions

  • Familial Chylomicronemia Syndrome

Interventions

DRUG

Volanesorsen

DRUG

Placebo

Sponsors & Collaborators

  • Akcea Therapeutics

    collaborator INDUSTRY

  • Ionis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-12-19
Completion
2017-03-28
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT02211209 on ClinicalTrials.gov