An Open-Label Study of AKCEA-APOCIII-LRX Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen (ISIS 304801)
- Conditions
- Familial Chylomicronemia SyndromeMedDRA version: 20.0Level: LLTClassification code: 10059191Term: Familial hypertriglyceridemia Class: 10010331MedDRA version: 20.1Level: LLTClassification code: 10020607Term: Hyperchylomicronemia Class: 10027433Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- CTIS2023-508815-22-00
- Lead Sponsor
- Ionis Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Patients with FCS (clinical or genetic diagnosis) currently on or previously treated with volanesorsen (ISIS 304801) Study participants in countries where Waylivra is commercially approved and available for patients should not be deprived of the treatment option with Waylivra. Participation in this study for such patients will only be allowed when Waylivra was discontinued due to AEs, Other protocol-defined inclusion criteria apply.
Treatment with another investigational drug (non-oligonucleotide), biological agent, or device within 4 weeks of Screening, or 5 half-lives of investigational agent, whichever is longer. Have any other conditions including significant medical history which, in the opinion of the Investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the Study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method