Ketotifen in Non-Alcoholic Fatty Liver Disease Patients
Launched by TANTA UNIVERSITY · Nov 13, 2022
Trial Information
Current as of July 06, 2025
Unknown status
Keywords
ClinConnect Summary
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 hepatoc...
Gender
ALL
Eligibility 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.
About Tanta University
Tanta University is a prestigious academic institution located in Egypt, dedicated to advancing medical research and education. As a clinical trial sponsor, Tanta University leverages its extensive resources and expertise to conduct innovative research initiatives aimed at improving health outcomes. The university collaborates with a network of healthcare professionals, researchers, and institutions to facilitate rigorous clinical trials across various medical disciplines. Committed to ethical standards and scientific integrity, Tanta University strives to contribute to the global body of knowledge while fostering the next generation of medical professionals.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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