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ACTIVE NOT RECRUITING
NCT05573204
PHASE2

Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis

Sponsor: Tanta University

View on ClinicalTrials.gov

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

Interventions

DRUG

Obeticholic Acid Oral Tablet

Obeticholic acid used as 10 mg tablet once daily for 6 months

DRUG

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