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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01589237
First received: April 27, 2012
Last updated: June 25, 2014
Last verified: June 2014

April 27, 2012
June 25, 2014
February 2013
November 2016   (final data collection date for primary outcome measure)
Number of patients wtih Adverse and Serious Adverse Events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
AE/SAE monitoring will occur. Gastrointestinal AEs and any symptoms of phototoxicity; events suggestive or diagnostic of acute pancreatitis and will be adjudicated.
Same as current
Complete list of historical versions of study NCT01589237 on ClinicalTrials.gov Archive Site
  • Changes in lipid and lipoprotein profiles from baseline up to 52 weeks [ Time Frame: Baseline, Week 12, 24 and 52 ] [ Designated as safety issue: No ]
    Fasting blood samples will be collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipid/lipoprotein profiles.
  • Changes from baseline in triglyceride levels up to 52 weeks [ Time Frame: Baseline, Week 12, 24 and 52 ] [ Designated as safety issue: No ]
    Blood samples will be collected for a fasting lipid panel, including total triglycerides. Lipid measurements should be collected after a 12 hour (overnight) fast. The maintenance of effect will be assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks in the full analysis set.
Same as current
Not Provided
Not Provided
 
Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.
An Open Label, 52-week, Safety and Tolerability Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.

This study is 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).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Familial Chylomicronemia Syndrome (FCS) (HLP Type I)
Drug: LCQ908
Experimental: LCQ908
Patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose will be allowed. One down titration allowed from the highest dose attained.
Intervention: Drug: LCQ908
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
November 2016
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed.
  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. 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.
  4. 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.
  5. Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is ≥ 8.5%.
  6. Treatment with fish oil preparations within 4 weeks prior to randomization.
  7. Treatment with bile acid binding resins (i.e., colesevelam, etc) within 4 weeks prior to randomization.
  8. Treatment with fibrates within 8 weeks prior to randomization. Washout may occur following screening if required.
  9. Glybera [alipogene tiparvovec (AAV1-LPLS447X )] gene therapy exposure within the two years prior to screening.
  10. eGFR <45 ml/min/1.73m2 or history of chronic renal disease.

Other protocol defined inclusion/exclusion criteria may apply.

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Canada,   France,   Germany,   Netherlands,   South Africa,   Spain,   United Kingdom
 
NCT01589237
CLCQ908B2305, 2012-000802-32
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP