NCT05051527已完成不适用
Observational, Single Arm, Prospective Study to Evaluate the Effectiveness of Legalon® in Addition to Diet and Exercise in Reducing Plasma Levels of Liver Enzymes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- effectiveness of Legalon®
研究概览
简要总结
This is a multinational, multicentre, prospective, non-interventional study (NIS) in non-alcoholic fatty liver disease (NAFLD) patients with concomitant metabolic syndrome treated with Legalon® combined with diet and exercise.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legalon® monotherapy prescribed by the treating Investigator according to the SPC, independently from and within a 4-week window prior to enrolment into the study.
- •Male/female, 18 years of age and older
- •Able to provide informed consent
- •Available baseline blood results not older than 4 weeks from inclusion, with elevated plasma level of at least one liver enzyme with respect to normal ranges of local laboratory (>1 UNL)
- •NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by the protocol of Ballestri
- •Presence of metabolic syndrome, defined as the presence of at least 3 out of 5 of the following:
- •Central obesity (for Asian population, waist circumference ≥90 cm in males, ≥80 cm in females)
- •Insulin resistance (fasting blood glucose ≥100mg/dl or under medication)
- •High blood pressure (≥ 130/85 mmHg or on medication)
- •High triglycerides (≥150 mg/dl or on medication)
- •Low HDL-cholesterol (<40mg/dl in men, <50mg/dl in women)
- •Started diet and exercise interventions, as per treating Investigator's suggestion and in line with current guidelines within a 4-week window prior to enrolment into the study
排除标准
- •Significant alcohol intake >7 standard alcoholic drinks per week (70 g ethanol) in women and >14 (140 g) in men
- •Received Legalon® or any other hepatoprotective treatment before the allowed 4-week window prior to enrolment into the study.
- •On diet and exercise before the allowed 4-week window prior to enrolment into the study.
- •Other concomitant established / diagnosed liver diseases, including chronic hepatitis B, chronic hepatitis C, autoimmune liver diseases (including autoimmune hepatitis), celiac disease, primary biliary cholangitis, primary sclerosing cholangitis, biliary obstruction, drug-induced liver disease (including herbal medicines and dietary supplements), metabolic liver disorders (such as Wilson's disease, alpha-1- antitrypsin deficiency, hemochromatosis, glycogen storage disorders, cholesterol storage disorders), severe liver diseases, non-alcoholic steatohepatitis (NASH) or other forms of advanced fatty liver disease (including clinically relevant fibrosis, >F2, or established cirrhosis), liver carcinoma
- •Patients treated with drugs with known hepatotoxic effects (at risk of drug-induced liver injury [DILI]), including herbal medicines and dietary supplements
- •Other major diseases that, in the treating Investigator opinion, can impair liver function, as for example type 1 diabetes
- •Pregnant and/or breastfeeding women
- •Persons that, in treating Investigator's opinion, are not able to fulfil study requirements
- •Persons that refuses to participate
- •Patients that, in the Investigator's opinion, are or have been infected with COVID-19 (i.e. presence/referral of COVID-19 symptoms or positive antigenic/molecular test)
研究组 & 干预措施
Legalon®
Legalon® 140 mg
干预措施: Legalon® 140 mg (Drug)
结局指标
主要结局
effectiveness of Legalon®
时间窗: 6 months
\- To observe the effectiveness of Legalon® in addition to diet and exercise in lowering the plasma levels of liver enzymes in patients with non-alcoholic fatty liver disease (NAFLD) and concomitant metabolic syndrome
次要结局
未报告次要终点
研究者
研究点 (1)
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