An Open-Label Extension Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
Who is this study for? Patients with familial chylomicronemia syndrome
What treatments are being studied? Olezarsen
Status: Active_not_recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• • Satisfactory completion of treatment with olezarsen in the index study (ISIS 678354-CS3, last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgement.
Locations
United States
California
Diabetes/Lipid Management & Research Center
Huntington Beach
Florida
Excel Medical Clinical Trials, LLC
Boca Raton
Illinois
Department of Pharmacy
Park Ridge
Kansas
University of Kansas Medical Center (KUMC)
Kansas City
New York
CTSI Investigational Pharmacy
New York
Milstein Hospital
New York
Pennsylvania
IDS Central
Philadelphia
Other Locations
Canada
Ecogene-21
Chicoutimi
Institute de Recherches Cliniques de Montreal
Montreal
Nathalie Saint-Pierre
Montreal
Clinique des Maladies Lipidiques de Quebec Inc.
Québec
France
Groupement Hospitalier Est- Pharmacie Secteur Essais Clinique
Bron
Hôpital Bicêtre
Le Kremlin-bicêtre
Pharmacie Hopital de la Conception
Marseille
Italy
Via Sergio Pansini 5
Napoli
UOC di Farmacia AOUP PAOLO GIACCONE
Palermo
Azienda Ospedaliero Universitaria Policlinico Umberto I
Rome
Netherlands
Academisch Medisch Centrum Goederenontvangst Apotheek t.a.v. Kenniscentrum
Amsterdam
Norway
Oslo Hospital Pharmacy Rikshospitalet
Oslo
Portugal
Hospital da Senhora da Oliveira Guimaraes
Creixomil
Dra Margarida Falcao Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz
Lisbon
Slovakia
Metabolicke centrum MU
Bratislava
Spain
Hospital Clínic Barcelona C/ Villarroel
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Virgen del Rocío
Seville
Sweden
Apokteket AB
Malmo
United Kingdom
Royal Manchester Children's Hospital
Manchester
Time Frame
Start Date: 2021-11-18
Completion Date: 2028-02
Participants
Target number of participants: 60
Treatments
Experimental: Olezarsen
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 153.
Related Therapeutic Areas
Sponsors
Leads: Ionis Pharmaceuticals, Inc.