Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

NCT05616442 | Completed Phase 4

• 1 other identifier: E112022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Disease

Keywords

Nonalcoholic fatty liver disease (NAFLD)

Outcome Measures

Primary Outcomes (1)

• fibrosis improvement (≥ 1 stage)

  F0: no fibrosis F1: portal fibrosis without septa by fibroscan

  up to 6 months

Secondary Outcomes (1)

• improvement of inflammatory biochemical markers as TNF

  up to 6 months

Study Arms (2)

Group 1 as Vitamine E group

EXPERIMENTAL

Vitamin E as standard therapy

Drug: Vitamin E

Group two as Ketotifen group

EXPERIMENTAL

Ketotifen as interventional

Drug: Ketotifen

Interventions

Ketotifen DRUG

Mast cell stabilizer

Group two as Ketotifen group

Vitamin E DRUG

Dietary supplement

Group 1 as Vitamine E group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 34518, Egypt

Location

MeSH Terms

Conditions

Digestive System Diseases; Non-alcoholic Fatty Liver Disease

Interventions

Ketotifen; Vitamin E

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator and clinical professor

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: May 20, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

EG (1)