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

ovartis Pharma Services AG0 个研究点目标入组 42 人开始时间: 2012年7月26日最近更新: 2016年6月27日

研究概览

暂无简介。

•- 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
•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 29
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 13

•-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.
•- Preganant 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 diabetus 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 two years prior to screening
•- eGFR < 45 ml/min/1.73m2 or history of chronic renal disease

发起方