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

NCT ID: NCT06302049

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-05-01

Brief 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.

Conditions

Fatty Liver Disease; Steatohepatitis, Nonalcoholic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

esomeprazole group

patients in this arm will receive esomeprazole 20 mg once daily

Group Type: EXPERIMENTAL

Esomeprazole

Intervention Type: DRUG

esomeprazole 20 mg once daily

Placebo group

patients in this arm will receive placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo once daily

Interventions

Esomeprazole

esomeprazole 20 mg once daily

Intervention Type: DRUG

Placebo

Placebo once daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sadat City University

OTHER

Sponsor Role: lead

Responsible Party

Aya Hesham Helmy Eltabbakh

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Liver Institute

Shibīn al Kawm, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

aya hesham eltabbakh, bachelor

Role: CONTACT

aya.eltabaakh@fop.usc.edu.eg

+201094393402

Facility Contacts

National Li Institute

Role: primary

0482222740

Other Identifiers

12345

Identifier Type: -

Identifier Source: org_study_id