An open-label clinical trial of volanesorsen in patients with Familial Chylomicronemia Syndrome (FCS)

Phase 1

• Conditions: MedDRA version: 18.1 Level: LLT Classification code 10060593 Term: Fredrickson Type I lipidemia System Organ Class: 100000004850; Familial Chylomicronemia Syndrome (FCS); MedDRA version: 18.1 Level: LLT Classification code 10017339 Term: Fredrickson Type I lipidaemia System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2015-003755-21-ES
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1. Satisfactory completion of ISIS 304801-CS6 or ISIS 304801-CS16 (index studies) with an acceptable safety profile
2. History of chylomicronemia
3. A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
4. Fasting triglycerides ? 750 mg/dL (8.4 mmol/L) at Screening for the index studies
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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;
2. Unwilling to comply with lifestyle requirements for the duration of the study.

Study & Design

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