Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis

Fatty Liver Disease Clinical Trial

Official title:

Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis: A Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06302049
• Other study ID #: 12345
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: March 2024
• Source: Sadat City University
• Contact: aya hesham eltabbakh, bachelor
• Phone: +201094393402
• Email: aya.eltabaakh[@]fop.usc.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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/ m2.
• 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.

Exclusion Criteria:

• Patients with a history of hypersensitivity to esomeprazole.
• Patients with BMI = 40 kg/ m2.
• 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

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver Disease
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Steatohepatitis, Nonalcoholic

Intervention

Drug:
• Esomeprazole
esomeprazole 20 mg once daily
• Placebo
Placebo once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sadat City University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS)	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)	Before and after 3 months of the intervention
Secondary	Liver function improvement	change in the other measured parameters such as liver panel	Before and after 3 months of the intervention
Secondary	Reduction of oxidative stress	Decrease in the serum level of malondialdehyde (MDA)	Before and after 3 months of the intervention