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Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis
Sponsor: Tanta University
Summary
This study aims at evaluating and comparing the protective outcomes of using Obeticholic acid versus Vitamin E in NASH patients without cirrhosis. The intervention is 6-months duration and the study will assess the efficacy of either drug as fibrosis improvement (≥ 1 stage) with no worsening of NASH or NASH resolution with no worsening of fibrosis with the study considered successful if either 1ry end point is met. . Also, assessment of biochemical markers related to steatosis, inflammation, oxidative stress, insulin resistance and liver fibrosis will be done.
Official title: Comparative Study Evaluating the Outcome of Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis Without Cirrhosis
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2021-09-01
Completion Date
2026-12-30
Last Updated
2025-01-10
Healthy Volunteers
No
Conditions
Interventions
Obeticholic Acid Oral Tablet
Obeticholic acid used as 10 mg tablet once daily for 6 months
Vit E
Vitamin E used as 400 mg soft gelatin capsules twice daily for 6 months
Locations (1)
Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine,Tanta University
Tanta, Egypt