Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the safety and efficacy of using ketotifen in patients with NAFLD patients without cirrhosis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Ketotifen; Vitamin E

Criteria

-Inclusion criteria: Adult 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

• 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.

• 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.

• Other anti-histaminic, sedating agents (CNS depressants) and anticholinergic medications.