NL-OMON36068招募中3 期
A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 microgram and 100 mircrogram/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care - KBT009/ Akka study
Karo Bio AB0 个研究点目标入组 160 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Patients with confirmed HeFH who are equal or above 18 years of age at screening.
- •2) Patients must also have:
- •Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C above 2 mmol/L at Visit 2; or
- •Presence of 2 or more risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C above 2.5 mmol/L at Visit 2:
- •3) Patients should be on an optimal standard of care, defined as being on a stable dose of statin with or without ezetimibe for at least 8 weeks prior to randomisation. If lower doses of rosuvastatin, atorvastatin, or simvastatin or any dose of fluvastatin or pravastatin are used the reasons must be clearly documented.
- •4) Patients must understand the study procedures and agree to participate in the study by giving written informed consent at Visit 1; and
- •5) Women must not be pregnant or lactating. Women of childbearing potential must use a medically acceptable form of contraception at least 4 weeks prior to the start of the study and for at least 4 weeks after the patient*s last study visit. Subjects who are on systemic hormonal contraceptives must agree to use an additional method of contraception (barrier method).
排除标准
- •Patients should not have other dyslipidaemic or metabolic disorders that could affect the evaluation of eprotirome in HeFH, such as increased serum TG above 4.5 mmol/L, HbA1c above 8.5%, secondary dyslipidaemia or ongoing or planned apharesis.
- •Patients should also not have cardiac diseases that may interfere with the safety evaluation of eprotirome, such as congestive heart failure (NYHA III and IV), planned percutaneous coronary intervention, coronary artery bypass surgery, uncontrolled hypertension or evidence of cardiac electrophysiologic instability including uncontrolled sick sinus syndrome, sino-atrial or atrioventricular block, ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia with a ventricular response heart rate or a QTcF above 450 ms prior to randomisation.
- •No other lipid-lowering medication with the exception of statins and ezetimibe are allowed. Also patients with any medical or surgical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study medication are excluded.
- •As eprotirome is a thyroid hormone receptor agonist, patients with disturbed thyroid function, thyrotoxicosis, taking thyroid hormone or anti-thyroid medication are excluded. Drugs known to affect thyroid function tests are also prohibited.
- •As eprotirome exerts its pharmacological action in the liver, patients with liver dysfunction should be excluded prior to randomisation, such as: AST or ALT or ALP above 1.5 x ULN, total bilirubin >ULN, active hepatobiliary disease, cholestasis, or serologic evidence of past or active hepatitis B or hepatitis C, acquired immune deficiency syndrome, positive serological test for human immunodeficiency virus infection, substantial consumption of alcohol or drug abuse.
- •Patients with serum creatinine above 160 mmol/L or unexplained serum creatine kinase above 3 x ULN are exluded.
- •Patients on oral anticoagulant therapy other than vitamin K antagonists and anti-platelet agents are excluded.
- •Patients with the following diseases are excluded: rheumatoid arthritis; history of cancer, history of or current primary or secondary adrenal insufficiency or any other condition that in the opinion of the investigator confound the evaluation and interpretation of efficacy and or safety data
研究者
相似试验
进行中（未招募）
不适用
/AHeterozygous Familial HypercholesterolaemiaMedDRA version: 14.0Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001483-21-CZKaro Bio AB1,050
进行中（未招募）
不适用
A clinical study on patients suffering from high level cholesterols. The aim is to evaluate safety and efficacy of a new medicinal drug.Heterozygous Familial HypercholesterolaemiaMedDRA version: 14.0Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001483-21-ATKaro Bio AB1,050
进行中（未招募）
不适用
Eprotirome in Patients with HeFH who are on Optimal Standard of CareEUCTR2011-001483-21-GBKaro Bio AB1,050
进行中（未招募）
1 期
A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 µg and 100 µg/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care - AKKAHeterozygous Familial HypercholesterolaemiaMedDRA version: 14.1Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001483-21-DKKaro Bio AB
进行中（未招募）
不适用
A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 µg and 100 µg/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care - AKKAHeterozygous Familial HypercholesterolaemiaMedDRA version: 14.1Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001483-21-SEKaro Bio AB1,050