NCT05616442CompletedPhase 4
Ketotifen in Non-Alcoholic Fatty Liver Disease Patients
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
The aim of this study is to investigate the safety and efficacy of using ketotifen in patients with NAFLD patients without cirrhosis
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 7 Nov 2022
- Start date
- 20 May 2023
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Tanta University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05616442
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 20 May 2023 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- -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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta Unuversity Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
Related publications
- Immunomodulatory and Anti-Inflammatory Effects of Ketotifen Versus Vitamin E in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized Pilot Study.Drug Des Devel Ther · 2026 · PMID 42039690
This page is information, not medical advice. Discuss any trial with your doctor.