Effect of LCQ908 in subjects with FCS - Extension Study
Research type
Research Study
Full title
An open label, 52-week, safety and tolerability extension to a randomized, double-blind, placebo controlled study of LCQ908 in subjects with Familial Chylomicronemia Syndrome.
IRAS ID
114336
Contact name
Handrean Soran
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-000802-32
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine the long term safety and effectiveness of the new investigational drug LCQ908, in lowering triglycerides (a type of fat) in subjects with a rare genetic disorder called Familial Chylomicronaemia Syndrome (FCS). FCS leads to very high lipid levels causing an increased risk of acute pancreatitis (sudden swelling/inflammation of the pancreas), which can be severe and life threatening. The study aims to determine the long term safety and effectiveness of LCQ908 over 52 weeks in patients that have previously taken part in the main study involving the same investigational drug LCQ908 (Protocol number: CLCQ9082302). Patients will receive LCQ908 for 52 weeks during which a strict very low fat diet, which is currently the only available treatment for this condition will have to be followed.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0719
Date of REC Opinion
7 Feb 2013
REC opinion
Further Information Favourable Opinion