2024-518334-88-00招募中4 期
Reducing Non-Alcoholic Steatohepatitis
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月8日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Decrease of a histological score of NASH
研究概览
简要总结
Evaluation of histological grade and NASH stage in patients with verified NASH during 48-week long empagliflozin therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The ability and eligibility to sign informed consent. • The age between 18 and 75 years of age at the beginning of the study. • Verified/excluded diagnosis of DM2T according to the cohort. (OGTT HbA1c). Verified diagnosis of NASH determined by histology no older than 6 months before the administration of medication. The activity of the process must be determined by NAFLD Activity Score – NAS. • Value of HbA1c ≤ 80 mmol/mol. • In women of child bearing age a willingness to use at least 2 contraceptive methods
排除标准
- •Contraindication of liver biopsy • A documented episode of ketoacidosis • Contraindication or hypersensitivity to empagliflozin • A presence of an acute or chronic disease that could endanger the safety or health of the patient by discretion of the examiner • Value of HbA1c > 80 mmol/mol. • The inability to exclude thiazolidinedione (pioglitazone) from chronic medication. • Liver affection of different etiology, including hepatitis B a C , autoimmune hepatitis, alpha-1 antitrypsin insufficiency, hemochromatosis, Wilson disease, primary sclerosing cholangitis, primary biliary cirrhosis or liver cirrhosis (Child-Pugh A, B, C) of any etiology • The use of drugs or medicine inducing steatosis or liver fibrosis. • Verified use of ethanol: men >30 g/day, woman > 20 g/day • History of acute o chronic pancreatitis. • Known abuse of and or an addiction to illegal substances • A verified fluctuation of body weight +/- 10 % in the last 3 months. • A diagnosis of a malignant disease (with the exclusion of threated dermal malignancies) in the last 5 years. • Cerebral stroke or cardiac infarction in the last 6 months. • Clinically significant shortness of breath defined as NYHA III or more. • Verified heart failure with associated decrease of ejection fraction of the left ventricle less than 40 %. • Values of eGFR lower than 30 ml/min/1,73 m2 or if CrCl is lower than 30 ml/min. • Syndrome of the diabetic foot with the need for amputation or an active ulcer • Planed pregnancy, active lactation or pregnancy, positivity in a pregnancy test, absence of at least 2 adequate contraceptive methods in women of fertile age. • Participation in a different study in the last 3 months before the start of the study. • Incapacity or diminished capacity to perform legal acts. • Pending execution of a sentence.
结局指标
主要结局
Decrease of a histological score of NASH
Decrease of a histological score of NASH
次要结局
- Decrease of fibrosis stage assessed by non-invasive liver elastography. Improvement of laboratory results and anthropometric data
研究者
Investigator
Scientific
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound DevicesNCT07268937Fondazione IRCCS Policlinico San Matteo di Pavia25
已完成
2 期
Phase 2b Study in NASH to Assess IVA337Non-Alcoholic Steatohepatitis (NASH)NCT03008070Inventiva Pharma247
招募中
不适用
A Multicenter, Double-blind, Placebo-randomized Controlled Clinical Study on the Treatment of Non-alcoholic Steatohepatitis With Tibetan Drug Langqing AtarNASHNCT06193629Shupei Li150
进行中（未招募）
不适用
Fibrosis Reduction in Non Alcoholic SteatohepatitisNASH With FibrosisWeight LossBariatric Surgery CandidateNCT05798702Fondazione Policlinico Universitario Agostino Gemelli IRCCS20
招募中
不适用
Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced FibrosisNonalcoholic SteatohepatitisNCT05720663Virginia Commonwealth University240