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Hyperlipoproteinemia Type II clinical trials

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NCT ID: NCT02489253 Recruiting - Clinical trials for Familial Hypercholesterolemia

Atherosclerosis in Familial Hypercholesterolemia

Start date: April 2014
Phase: N/A
Study type: Observational

Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in 500 in the UK. Our aim is compare the carotid and coronary artery atherosclerosis in monogenic FH and polygenic hypercholesterolemia with means of a carotid ultrasound, a coronary CT angiogram and biochemical biomarkers.

NCT ID: NCT02472535 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Study to Evaluate the Effects of MBX-8025 in Patients With HoFH

Start date: April 2015
Phase: Phase 2
Study type: Interventional

A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH).

NCT ID: NCT02462655 Completed - Clinical trials for Familial Hypercholesterolemia

Effects of LDL Apheresis System on the Expression of Genes Involved in Lipoprotein Metabolism and Inflammation in Homozygotes for Familial Hypercholesterolemia

LA-PBMC
Start date: October 2015
Phase: N/A
Study type: Interventional

Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by mutations in the LDL receptor gene that disrupt the normal clearance of LDL particles from the plasma compartment. Heterozygous patients present a 2- to 3-fold raise in plasma LDL-cholesterol (C) concentrations, tendinous xanthomatosis and premature atherosclerotic coronary heart disease (CHD), usually occurring between the age of 35 and 55 years. Since the mid-1970s, LDL-C has been removed from the blood of patients using plasmapheresis, and this technique has been shown to improve the life expectancy of FH homozygotes. LDL apheresis selectively removes LDL particles but not immunoglobulins and other beneficial proteins, thereby overcoming a potential drawback of the traditional plasmapheresis method. LDL-C is effectively reduced by more than 60% immediately after LDL apheresis, although LDL levels rebound rapidly. Dextran sulfate adsorption is a commonly apheresis technique used in familial hypercholesterolemia patients. In this apheresis plasma is separated from red blood cells and passed over columns of cellulose beads containing dextran sulfate which binds apolipoprotein B (apoB) by a highly selective electrostatic binding mechanism. Since LDL, very-low density lipoprotein (VLDL), and Lipoprotein (a) all contain apoB, dextran sulfate adsorption apheresis selectively reduces these lipoproteins while having little effect on the non-apoB containing HDL particles. In clinical practice, LDL apheresis reduces the rate of future cardiovascular events and has been postulated to have additional effects on potentially pro-atherogenic factors. Some proteins have been identified with adhesive characteristics to lipoproteins, rheological, immunological and inflammation relevant proteins16-19 that influence microcirculation as well as the inflammatory response. However, no studies have yet to investigate the impact of LDL apheresis on the expression of different genes involved in cardiovascular disease. The main objective of the present research project is to investigate the impact of the LDL apheresis dextran sulfate adsorption system on the messenger ribonucleic acid (mRNA) expression of genes involved in cardiovascular disease using microarrays analysis in 9 FH homozygotes.

NCT ID: NCT02460159 Completed - Clinical trials for Hypercholesterolemia

A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)

Start date: June 23, 2015
Phase: Phase 3
Study type: Interventional

This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.

NCT ID: NCT02434497 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia (HoFH)

A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Start date: June 6, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.

NCT ID: NCT02399852 Withdrawn - Clinical trials for Homozygous Familial Hypercholesterolemia

Effects of Lomitapide on Carotid and Aortic Atherosclerosis

Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.

NCT ID: NCT02392559 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders

HAUSER-RCT
Start date: March 24, 2016
Phase: Phase 3
Study type: Interventional

A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.

NCT ID: NCT02326220 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy

ODYSSEY ESCAPE
Start date: March 31, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekly LDL apheresis therapy.

NCT ID: NCT02286596 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia

APHERESE
Start date: April 2013
Phase: N/A
Study type: Observational

Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been proved to be a reliable method to decrease LDL-C concentrations and therefore decrease cardiovascular disease risk in HoFH. The objective of this crossover study was to compare efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and LDL particles size in a cohort of HoFH subjects.

NCT ID: NCT02265952 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Start date: February 4, 2015
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).