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Clinical Trials/NL-OMON41457
NL-OMON41457
Completed
Phase 3

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

ovartis0 sites9 target enrollmentTBD
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ConditionsFamilial Chylomicronemia Syndrome10013317

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Familial Chylomicronemia Syndrome
Sponsor
ovartis
Enrollment
9
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
May 30, 2015
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
ovartis

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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