Clinical Effects of New Approach on Patients With Non-alcoholic Steatohepatitis

• Status: Not yet recruiting
• Trial end date: 2025-01-17
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate and compare the protective outcomes of using Rosuvastatin, Vitamin E, and N-acetyl cysteine in Egyptian patients with NASH.

The primary endpoint of this 3-month study would be an improved degree of fibrosis with no worsening of NASH or NASH resolution with no worsening of fibrosis and steatosis that the study considered successful if either 1ry endpoint is met.

The secondary endpoint of this study is the improvement of biochemical markers related to steatosis, inflammation, oxidative stress, insulin resistance, and liver fibrosis.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University
• Treatments: Acetylcysteine; N-monoacetylcystine; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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.

• NASH diagnosis using Fibroscan detecting the degree of steatosis and fibrosis.

• NASH diagnosis is by non-invasive Scoring such as (FAST Score) Cytokeratin-18 >240 U/L Mild to moderate elevation of hepatic liver enzymes: serum aminotransferases (>2 but <5 times upper normal limit)

• Stable dietary habits and physical activity pattern.

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.

• The presence of contra-indications of NAC or rosuvastatin.

• 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.

• If there are any conditions where fibroscan could be contra-indicated. The patients refuse participating or completing study.