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Clinical Trial Summary

The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS).


Clinical Trial Description

The Expanded Access Program (EAP) is intended to provide pre-approval access to olezarsen for eligible patients with FCS who have limited or no available treatment options. This program is open in the United States and operates under the individual patient (also referred to as single patient) IND expanded access route in which the patient's treating physician serves as the sponsor. Expanded access requests must be from the patient's treating physicians and submitted according to the instructions at https://www.ionispharma.com/patients/expanded-access-policy/ ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06360237
Study type Expanded Access
Source Ionis Pharmaceuticals, Inc.
Contact Ionis Pharmaceuticals Medical Information
Phone 1-833-644-6647 (833-MI-IONIS)
Email MedInfo@ionisph.com
Status Available
Phase

See also
  Status Clinical Trial Phase
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Active, not recruiting NCT05130450 - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS) Phase 3
Completed NCT04568434 - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) Phase 3
Completed NCT03912181 - Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes
Not yet recruiting NCT05902598 - A Phase 3 Study of VSA001 in Chinese Adults With Familial Chylomicronemia Syndrome Phase 3
Active, not recruiting NCT05185843 - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen Phase 3
Completed NCT02658175 - The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome Phase 3
Completed NCT03360747 - Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS) Phase 2
Completed NCT02211209 - The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome Phase 3