Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis: A Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS)
研究概览
简要总结
The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both males and females.
- •Diabetic and non-diabetic patients.
- •Age >18 years old.
- •Overweight and obese patient: Body mass index (BMI) ≥ 25 kg/ m2 but <40 kg/ m
- •Patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome and helicobacter pylori infection.
- •Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (>2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, HAIR score of 2 or 3.
排除标准
- •Patients with a history of hypersensitivity to esomeprazole.
- •Patients with BMI ≥ 40 kg/ m
- •Patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are CYP2C19 substrates.
- •Patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine.
- •Patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease and alpha-1 antitrypsin deficiency.
- •Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate.
- •Patients with cancer or with a history of cancer.
- •Patients with cardiovascular diseases.
- •Pregnant and lactating females
研究组 & 干预措施
esomeprazole group
patients in this arm will receive esomeprazole 20 mg once daily
干预措施: Esomeprazole (Drug)
Placebo group
patients in this arm will receive placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS)
时间窗: Before and after 3 months of the intervention
Increase in NAFLD fibrosis score indicates high probability of advanced liver fibrosis Score lower than -1.5 indicates low probability of advanced liver fibrosis (F0-F2). Score higher than or equals -1.5 to \< 0.67 indicates intermediate probability of advanced liver fibrosis. Score higher than or equals 0.67 indicates high probability of advanced liver fibrosis (F3-F4)
次要结局
- Liver function improvement(Before and after 3 months of the intervention)
- Reduction of oxidative stress(Before and after 3 months of the intervention)
研究者
Aya Hesham Helmy Eltabbakh
Demonstrator
Sadat City University