An open label, long term, safety and tolerability extension to a randomized, double-blind, placebo controlled study of LCQ908 in subjects with Familial Chylomicronemia Syndrome
- Conditions
- Familial Chylomicronemia Syndrome10013317
- Registration Number
- NL-OMON41457
- Lead Sponsor
- ovartis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
1. Written informed consent
2. Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after 52 weeks or FCS subjects who have previously completed study CLCQ908A2212
1. Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug related adverse events
2. Subjects from the CLCQ908B2302 study who have developed any other contraindication to participation (for example, renal failure)
3. Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is * 8.5%.
4. Treatment with fish oil preparations within 4 weeks prior to randomization
5. Treatment with bile acid binding resins (i.e. colesevelam etc) within 4 weeks prior to randomization
6. Treatment with fibrates within 8 weeks prior to randomization.
7. eGFR < 45 ml/min/1.73m2 or history of chronic renal disease
8. Glybera [alipogene tiparvovec (AAV1-LPLS447X)] gene therapy exposure within two years prior to screening
9. Pregnant or nursing (lactating) women.
10. Women of child-bearing potential not using highly effective methods of contraception during dosing and for 100 days after discontinuation of investigational study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of patients with adverse and serious adverse events</p><br>
- Secondary Outcome Measures
Name Time Method <p>Changes in lipid and lipoprotein profiles from baseline up to week 12, week 24<br /><br>and week 52<br /><br>Changes from baseline in triglyceride levels up week 12, week 24 and week 52</p><br>