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

NCT05573204 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-01-10

No results posted yet for this study

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.

Conditions

  • Non-alcoholic Steatohepatitis

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Hadier m. El-sheikh · Department of Clinical pharmacy, Faculty of Pharmacy, Tanta university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2026-10-25
Completion
2026-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573204 on ClinicalTrials.gov