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

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 - LCQ908 extension study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41457

Enrollment

Registered

2012-10-02

Start date

2013-10-31

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Chylomicronemia Syndrome

Interventions

Intervention consists of LCQ908 10 mg, LCQ908 20 mg or LCQ908 40 mg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Number of patients with adverse and serious adverse events	—

Secondary

Measure	Time frame
Changes in lipid and lipoprotein profiles from baseline up to week 12, week 24 and week 52 Changes from baseline in triglyceride levels up week 12, week 24 and week 52	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)