A Phase 1/2 interventional study of Esomeprazole and Placebo in Fatty Liver Disease and Steatohepatitis, Nonalcoholic, sponsored by Sadat City University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Sadat City University · Phase 1/2, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 46 is close to the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Sadat City University is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Both males and females.
Exclusion Criteria:
patients in this arm will receive esomeprazole 20 mg once daily
Drug: Esomeprazole
patients in this arm will receive placebo once daily
Drug: Placebo
esomeprazole 20 mg once daily
Placebo once daily
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)
Time frame: Before and after 3 months of the intervention
Liver function improvement
change in the other measured parameters such as liver panel
Time frame: Before and after 3 months of the intervention
Reduction of oxidative stress
Decrease in the serum level of malondialdehyde (MDA)
Time frame: Before and after 3 months of the intervention
Plan to share: No — Data will be supplied upon a reasonable request
No publications or documents are linked to this record.
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Sadat City University