Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)
NCT06360237 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2024-12-27
Summary
The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS).
Conditions
- Familial Chylomicronemia Syndrome
Interventions
- DRUG
-
Olezarsen
Olezarsen 80 mg administered once monthly by subcutaneous (SC) injections in the abdomen, thigh, or upper arm.
Sponsors & Collaborators
-
Ionis Pharmaceuticals, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
More Related Trials
-
Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
NCT00743483 ·Status: COMPLETED ·Phase: PHASE2
-
A Cross-over Study of OligoG in Subjects With Cystic Fibrosis. Fibrosis
NCT01465529 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
NCT06747858 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor
NCT05538585 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients with Cystic Fibrosis
NCT03822455 ·Status: TERMINATED ·Phase: PHASE2
-
Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans
NCT01273207 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients
NCT02532764 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
NCT06526923 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508del
NCT02653027 ·Status: WITHDRAWN ·Phase: NA
-
Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation
NCT02589236 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists
NCT06299696 ·Status: COMPLETED ·Phase: PHASE1
-
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
NCT03125395 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis
NCT00970346 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
NCT04279769 ·Status: COMPLETED ·Phase: PHASE1
-
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
NCT02137382 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis
NCT03647228 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.
NCT03589313 ·Status: COMPLETED ·Phase: PHASE1
-
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
NCT00690820 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis
NCT03029455 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations
NCT02934698 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation
NCT03068312 ·Status: COMPLETED ·Phase: PHASE3
-
Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation)
NCT02690519 ·Status: COMPLETED ·Phase: PHASE2
-
Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis
NCT03278314 ·Status: APPROVED_FOR_MARKETING
-
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis.
NCT05712538 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)
NCT06299709 ·Status: COMPLETED ·Phase: PHASE1