Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.

Stopped early · Phase 3

Conditions studied: Familial Chylomicronemia Syndrome (FCS) (HLP Type I)

In brief

This study was to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS) (HLP type I).

Key facts

Study ID

NCT01589237

Run by

Novartis Pharmaceuticals

People needed

38

Starts

2013-02-01

Expected to finish

2015-07-01

Last updated by the study team

2016-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent must be obtained before any assessment is performed.
• Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after 52 weeks or FCS subjects who have previously completed study CLCQ908A2212.

You may not qualify if…

• Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug related adverse events.
• Subjects from the CLCQ908B2302 study who have developed any other contraindication to participation (for example, renal failure)
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is ≥ 8.5%.
• Treatment with fish oil preparations within 4 weeks prior to randomization.
• Treatment with bile acid binding resins (i.e., colesevelam, etc) within 4 weeks prior to randomization.
• Treatment with fibrates within 8 weeks prior to randomization. Washout may occur following screening if required.
• Glybera [alipogene tiparvovec (AAV1-LPLS447X )] gene therapy exposure within the two years prior to screening.
• eGFR <45 ml/min/1.73m2 or history of chronic renal disease.
• Other protocol defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Seatlle, Washington, United States
• Novartis Investigative Site — Chicoutimi, Quebec, Canada
• Novartis Investigative Site — Ste-Foy, Quebec, Canada
• Novartis Investigative Site — Ouest-Montreal, Canada
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Meibergdreef 9, Netherlands
• Novartis Investigative Site — Cape Town, South Africa
• Novartis Investigative Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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