Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

NCT ID: NCT05616442

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-12-30

Brief Summary

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

Detailed Description

Nonalcoholic fatty liver disease (NAFLD) is characterized by the accumulation and deposition of fats in the hepatocytes which affect the liver structure and function. Causes of NAFLD vary but mainly attributed to dyslipidemia and obesity. Prevalence of NAFLD has been raised over years from 25% in 2005 to over 37% in 2016 and continues to increase to become one of the most common chronic liver disease (Li J et al., 2019).

The disease progress from steatosis and inflammatory infiltration that is known as nonalcoholic steatohepatitis (NASH) to liver fibrosis, cirrhosis, and ultimately hepatocellular carcinoma. Despite these serious outcomes, no definitive known approved medication for NASH has been developed. NAFLD management is mainly dependent on diet control, physical activity, and some supportive treatments mainly to prevent the disease complications (Mundi et al., 2020).

Mast cells (MCs) are responsible releasing mediators, including preformed bioactive metabolites (histamine and tryptase,), newly synthesized cytokines [transforming growth factor beta (TGF-β), tumor necrosis factor alpha (TNF-α) (Pham et al., 2022). MCs can lead to microvesicular steatosis, ductal reaction (DR), biliary senescence, inflammation, angiogenesis, and liver fibrosis during NAFLD/NASH (Huang et al., 2022). Consequently, MC stabilizer such as ketotifen has emerged as promising approach to improve patients with NASH through its antioxidant and anti-inflammatory effects (Kim et al., 2014; Abdelzaher et al., 2020).

Conditions

Hepatic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 as Vitamine E group

Vitamin E as standard therapy

Group Type: EXPERIMENTAL

Vitamin E

Intervention Type: DRUG

Dietary supplement

Group two as Ketotifen group

Ketotifen as interventional

Group Type: EXPERIMENTAL

Ketotifen

Intervention Type: DRUG

Mast cell stabilizer

Interventions

Ketotifen

Mast cell stabilizer

Intervention Type: DRUG

Vitamin E

Dietary supplement

Intervention Type: DRUG

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Eman Elberri

principal investigator and clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

E112022

Identifier Type: -

Identifier Source: org_study_id