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

• Status: Active, not recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Vitamin E

Criteria

Inclusion Criteria:

• Males or females aged ≥18 years.

• All patients are diagnosed to have fatty liver grading 1, 2 or 3 on abdominal ultrasound with Hepatic steatosis index > 36 to be considered as a NAFLD patient.

• Confirmed diagnosis of NASH using at least three of the following non-invasive tests:

• HAIR score

• Fibroscan detecting steatosis with F0-3 fibrosis stage

• Cytokeratin-18 >240 U/L

• Mild to moderate elevation of serum aminotransferases (>2 but <5 times upper normal limit)

Exclusion Criteria:

• Current or history of significant alcohol consumption.

• Use of drugs historically associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins).

• Prior or planned bariatric surgery.

• Uncontrolled diabetes defined as Hemoglobin A1c 9.5% or higher.

• Evidence of other forms of chronic liver disease as Hepatitis B, Hepatitis C, Wilson's disease, Alpha-1-antitrypsin(A1AT) deficiency, Hemochromatosis, drug-induced liver disease.

• Serum creatinine of 2.0 mg/dL or greater.

• Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial and breast feeding.

• Use of other drugs known to have possible positive effects on steatosis.