An Open-Label Extension Study of AKCEA-APOCIII-LRX Administered to Patients with Familial Chylomicronemia Syndrome (FCS)

Phase 1

• Conditions: Familial Chylomicronemia Syndrome (FCS); MedDRA version: 20.1Level: LLTClassification code: 10020607Term: Hyperchylomicronemia Class: 10027433; MedDRA version: 20.0Level: PTClassification code: 10059183Term: Familial hypertriglyceridaemia Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2023-509029-29-00
• Lead Sponsor: Ionis Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Satisfactory completion of the ISIS 678354 CS3 index study (last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgement, Willing to follow a diet comprising = 20 g fat per day during the study

Exclusion Criteria

Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study, including need for treatment with medications disallowed in the index study (ISIS 678354-CS3)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified