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Hyperlipoproteinemia Type II clinical trials

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NCT ID: NCT04507984 Completed - Clinical trials for Familial Hypercholesterolemia

Universal Familial Hypercholesterolemia Screening in Children

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

30 million individuals globally with undiagnosed familial hypercholesterolemia (FH) are at a substantial cardiovascular disease (CVD) risk, which could be normalized by early diagnosis and treatment. Effective screening strategies are urgently needed, but the data on universal FH screening (uFHs) is scarce. The investigators aim to assess the overall performance of the uFHs program in Slovenia and to compare the common elements to the pilot uFHs program in Lower Saxony (LS; Germany).

NCT ID: NCT04494464 Completed - Clinical trials for Familial Hypercholesterolemia

Treatment Rates and Compliance to Treatment in Patients With Familial Hypercholesterolemia

Start date: January 2017
Phase:
Study type: Observational [Patient Registry]

Familial hypercholesterolemia is a genetic disease characterized by increased levels of low density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite relatively high prevalence and significant association with increased mortality.

NCT ID: NCT04419090 Completed - Clinical trials for Familial Hypercholesterolemia

Cascade Genetic Testing of Familial Hypercholesterolemia

CATCH
Start date: November 10, 2020
Phase: N/A
Study type: Interventional

Familial hypercholesterolemia (FH) is a frequent genetic disorder (1/200) associated with an increased risk of early-onset myocardial infarction. To improve detection and treatment of patient with FH, cascade genetic testing in families is recommended by many cardiovascular prevention guidelines. However, the implementation of national genetic cascade screening is challenging, because legal protection to guarantee privacy of data do not authorize physicians to directly contact at-risk relatives. Using current mobile information technologies and a centralized web-based platform, we designed an ethical genetic cascade screening program for FH to be tested in Switzerland.

NCT ID: NCT04261803 Completed - Clinical trials for Hyperlipoproteinemia Type II

FH Detection in Children by Salivary Test

DEPEDIACOL
Start date: February 18, 2020
Phase:
Study type: Observational

Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. Studies on families of Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. The difference between Hypercholesterolemia and normal children in their atherogenic profil begin at the age of Nowadays , systematic screening techniques are not well implemented whereas their are clear World health organization guidelines. International studies show treatment must be initiated early as at the age of eight years old. In pediatry, Parents can be reluctant to practice blood test on their children. In order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test. The main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.

NCT ID: NCT04233918 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

Start date: June 29, 2020
Phase: Phase 3
Study type: Interventional

The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH). The primary objective for Part B of the study is to demonstrate a reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab in pediatric (5 to 11 years of age) patients with HoFH. The secondary objective for Part A of the study is to evaluate the safety and tolerability of evinacumab administered intravenous (IV) in pediatric patients with HoFH. The secondary objectives for Part B of the study are: - To evaluate the effect of evinacumab on other lipid parameters (ie, apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a [Lp(a)]) in pediatric patients with HoFH - To evaluate the safety and tolerability of evinacumab administered IV in pediatric patients with HoFH - To assess the PK of evinacumab in pediatric patients with HoFH - To assess the immunogenicity of evinacumab in pediatric patients with HoFH over time - To evaluate patient efficacy by mutation status

NCT ID: NCT04179669 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Safety and Efficacy of IBI306 in HeFH Patients

Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol (LDL-C) uptake. In the phase I study, IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.

NCT ID: NCT04173793 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

Start date: November 18, 2019
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients with HeFH.

NCT ID: NCT04148001 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia (HoFH)

Identifying and Genotyping Homozygous Familial Hypercholesterolemia (HoFH) Patients

Start date: December 4, 2019
Phase:
Study type: Observational

This study is designed to help identify patients with HoFH due to mutations in the LDLR as confirmed by genotyping.

NCT ID: NCT04118348 Completed - Clinical trials for Hypercholesterolemia

Evaluating the Efficacy of Pediatric Lipid Screening Alerts

Start date: October 10, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate prospectively the impact of different system alerts on the prescription of lipid panels to pediatric Geisinger patients (9-11 years old), as per the now-universal guidelines. This will help quantify the relative effectiveness of different alerts and combinations of alerts on provider prescribing behavior and patient uptake of screening.

NCT ID: NCT04034485 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH

Start date: December 7, 2019
Phase: Phase 3
Study type: Interventional

To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks [Q4W]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy