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Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

Primary Purpose

Hepatic Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketotifen
Vitamin E
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Disease focused on measuring Nonalcoholic fatty liver disease (NAFLD)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

-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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group 1 as Vitamine E group

    Group two as Ketotifen group

    Arm Description

    Vitamin E as standard therapy

    Ketotifen as interventional

    Outcomes

    Primary Outcome Measures

    fibrosis improvement (≥ 1 stage)
    F0: no fibrosis F1: portal fibrosis without septa by fibroscan

    Secondary Outcome Measures

    improvement of inflammatory biochemical markers as TNF
    tumor necrosis factor measured by ELISA

    Full Information

    First Posted
    November 7, 2022
    Last Updated
    November 13, 2022
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05616442
    Brief Title
    Ketotifen in Non-Alcoholic Fatty Liver Disease Patients
    Official Title
    Ketotifen in Non-Alcoholic Fatty Liver Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatic Disease
    Keywords
    Nonalcoholic fatty liver disease (NAFLD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 as Vitamine E group
    Arm Type
    Experimental
    Arm Description
    Vitamin E as standard therapy
    Arm Title
    Group two as Ketotifen group
    Arm Type
    Experimental
    Arm Description
    Ketotifen as interventional
    Intervention Type
    Drug
    Intervention Name(s)
    Ketotifen
    Intervention Description
    Mast cell stabilizer
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin E
    Intervention Description
    Dietary supplement
    Primary Outcome Measure Information:
    Title
    fibrosis improvement (≥ 1 stage)
    Description
    F0: no fibrosis F1: portal fibrosis without septa by fibroscan
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    improvement of inflammatory biochemical markers as TNF
    Description
    tumor necrosis factor measured by ELISA
    Time Frame
    up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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    Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

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