Febuxostat Versus Allopurinol on Hepatic Steatosis in MAFLD Patients

July 30, 2023 updated by: Ain Shams University

Allopurinol Versus Febuxostat: A New Approach for Management of Hepatic Steatosis in Metabolic-Associated Fatty Liver Disease

Metabolic associated fatty liver disease (MAFLD) is the most common and harmful chronic liver disease, and it is increasingly diagnosed in many developed and developing countries.

Previous studies suggested a significant association between hyperuricemia and MAFLD and that hyperuricemia plays a causal role in the development of MAFLD.

Xanthine oxidase is a key enzyme in uric acid metabolism, and It thus can be considered as is a therapeutic target for MAFLD, so long-term urate-lowering therapy may play a role in amelioration of MAFLD by controlling uric acid levels. So, this study is conducted to assess the effect of controlling hyperuricemia using different xanthine oxidase inhibitors on amelioration of MAFLD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effect of urate lowering therapy on improvement of steatosis in metabolic associated fatty liver disease (MAFLD) patients with hyperuricemia, by comparing two xanthine oxidase inhibitors allopurinol (100 mg/day), versus Febuxostat (40 mg/day), versus lifestyle intervention.

Primary Outcome: Regression of hepatic steatosis. Secondary Outcome: Improvement of Serum uric acid and incidence of hepatotoxicity.

Study design: This study is a prospective, interventional three arm study. Setting: Patients will be recruited from the National Hepatology and Tropical Medicine Research institute, Cairo, Egypt.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • National Hepatology and Tropical Medicine Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 18-65.
  • Males and Females

  • Metabolic syndrome according to the NCEP ATP III definition [13]: present of three or more of the following five criteria are met:

    • Waist circumference over 40 inches (men) or 35 inches (women), Central obesity - defined as waist circumference ≥ 102 cm for Men and ≥ 88 cm for women
    • Blood pressure over 130/85 mmHg,
    • Basting triglyceride (TG) level over 150 mg/dl,
    • Fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women),
    • Fasting blood sugar over 100 mg/dl.
  • Serum uric acid levels of > 420μmol/L (>7 mg/dL) in men and >360 μmol/L (>6 mg/dL) women.

Exclusion Criteria:

  • Renal insufficiency defined by serum creatinine > 2.0 mg/dl.

    • Patients with obvious abnormal liver function: serum transaminase (ALT, AST, one of them) exceed 2 times the upper limit of normal reference value.
    • Have a history of viral hepatitis, or serological examination suggests hepatitis virus infection, or have a history of other liver diseases.
    • Complementation with diabetes, or fasting blood glucose >7.8mmol/L, or HbA1c >7.5%.
    • Severe hypertension, blood pressure ≥ 160/100 mmHg.
    • A history of allergy to febuxostat and allopurinol; in the acute active phase of gout.
    • Drinking equivalent to alcohol intake ≥30g/d(male), ≥20g/d(female).
    • Complicated coronary heart disease.
    • Cardiac dysfunction (cardiac function grade 2 or above).
    • Patients with asthma and other respiratory diseases.
    • Intestinal diseases such as inflammatory bowel disease.
    • Any history of systemic malignancy in the past 5 years.
    • Use of uric-lowering drugs in the 4 weeks before screening: febuxostat, allopurinol, benzbromarone.
    • Morbid obesity (BMI>37.5kg/m2).
    • Triglyceride ≥5.0 mmol/L was found to be significantly abnormal in baseline examination.
    • had received systemic hormone or immunosuppressive therapy within 3 months prior to screening or expected to receive hormone or immunosuppressive therapy in the future.
    • Use of other drugs affecting uric acid metabolism were adjusted within 4 weeks before screening: losartan, fenofibrate, irbesartan, thiazide diuretics, loop medullar diuretics, compound antihypertensive agents containing diuretics.

Other drugs that may affect liver fat content were taken within 4 weeks before screening.

  • Women who are lactating or pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allopurinol group
Allopurinol (100 mg/day) plus lifestyle intervention
Drug: Allopurinol (100 mg/day) plus lifestyle intervention
participants accept allopurinol treatment (100 mg, once a day, orally). Behavioral: lifestyle intervention According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).
Other Names:
  • Allopurinol group
Experimental: Febuxostat group
Febuxostat (40 mg/day) plus lifestyle intervention
Drug: Febuxostat 40 mg plus lifestyle intervention
participants accept Febuxostat treatment (100 mg, once a day, orally). Behavioral: lifestyle intervention According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).
Other Names:
  • Febuxostat group
Active Comparator: lifestyle intervention
diet and exercise
Behavioral: Life style intervention
According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hepatic steatosis .
Time Frame: 3 months

FibroScan instrument measures fibrosis (scarring) and steatosis (fatty changes) in your liver. Fatty changes are when fat builds up in your liver cells.

FibroScan steatosis result (CAP score): decibels per meter(dB/M). it ranges from 100 to 400 dB/m. The fibrosis result is measured in kilopascals (kpa). It is normaly between 2 and 6 kpa.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum uric acid.
Time Frame: three months
change in serum uric milligrams/deciliter (mg/dl) in hyperuricemia patients. Normal values are 1.5 to 6.0 (mg/dl).
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Sarah Ma Zaki, Ass.Prof., Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

January 28, 2023

Study Completion (Actual)

January 28, 2023

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

July 23, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Febuxostat versus allopurinol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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