Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05474560
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2022-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Febuxostat Versus Allopurinol on Hepatic Steatosis in MAFLD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000493', 'term': 'Allopurinol'}, {'id': 'D000069465', 'term': 'Febuxostat'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 90 subjects are enrolled in this study. After the initial screening, the subjects were randomly divided into the control group and the drug treatment group. The control group was given lifestyle intervention for 24 weeks, and the experimental group was given febuxostat oral therapy or allopurinol oral therapy on the basis of lifestyle intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2022-07-23', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hepatic steatosis .', 'timeFrame': '3 months', 'description': 'FibroScan instrument measures fibrosis (scarring) and steatosis (fatty changes) in your liver. Fatty changes are when fat builds up in your liver cells.\n\nFibroScan 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.'}], 'secondaryOutcomes': [{'measure': 'Serum uric acid.', 'timeFrame': 'three months', 'description': 'change in serum uric milligrams/deciliter (mg/dl) in hyperuricemia patients. Normal values are 1.5 to 6.0 (mg/dl).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fatty liver disease', 'Hyperuricemia', 'Allopurinol', 'Febuxostat'], 'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Hyperuricemia']}, 'referencesModule': {'references': [{'pmid': '26395162', 'type': 'BACKGROUND', 'citation': 'Liu Z, Que S, Zhou L, Zheng S. Dose-response Relationship of Serum Uric Acid with Metabolic Syndrome and Non-alcoholic Fatty Liver Disease Incidence: A Meta-analysis of Prospective Studies. Sci Rep. 2015 Sep 23;5:14325. doi: 10.1038/srep14325.'}, {'pmid': '28930295', 'type': 'BACKGROUND', 'citation': 'Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.'}, {'pmid': '28790228', 'type': 'BACKGROUND', 'citation': 'Darmawan G, Hamijoyo L, Hasan I. Association between Serum Uric Acid and Non-Alcoholic Fatty Liver Disease: A Meta-Analysis. Acta Med Indones. 2017 Apr;49(2):136-147.'}, {'pmid': '28941364', 'type': 'BACKGROUND', 'citation': 'Allen AM, Therneau TM, Larson JJ, Coward A, Somers VK, Kamath PS. Nonalcoholic fatty liver disease incidence and impact on metabolic burden and death: A 20 year-community study. Hepatology. 2018 May;67(5):1726-1736. doi: 10.1002/hep.29546. Epub 2018 Mar 23.'}, {'pmid': '10583019', 'type': 'BACKGROUND', 'citation': 'Turnheim K, Krivanek P, Oberbauer R. Pharmacokinetics and pharmacodynamics of allopurinol in elderly and young subjects. Br J Clin Pharmacol. 1999 Oct;48(4):501-9. doi: 10.1046/j.1365-2125.1999.00041.x.'}, {'pmid': '30442825', 'type': 'BACKGROUND', 'citation': 'Lee JS, Won J, Kwon OC, Lee SS, Oh JS, Kim YG, Lee CK, Yoo B, Hong S. Hepatic Safety of Febuxostat Compared with Allopurinol in Gout Patients with Fatty Liver Disease. J Rheumatol. 2019 May;46(5):527-531. doi: 10.3899/jrheum.180761. Epub 2018 Nov 15.'}, {'pmid': '21054885', 'type': 'BACKGROUND', 'citation': 'Moy FM, Bulgiba A. The modified NCEP ATP III criteria maybe better than the IDF criteria in diagnosing Metabolic Syndrome among Malays in Kuala Lumpur. BMC Public Health. 2010 Nov 6;10:678. doi: 10.1186/1471-2458-10-678.'}, {'pmid': '20560813', 'type': 'BACKGROUND', 'citation': 'Kuo CF, Yu KH, Luo SF, Chiu CT, Ko YS, Hwang JS, Tseng WY, Chang HC, Chen HW, See LC. Gout and risk of non-alcoholic fatty liver disease. Scand J Rheumatol. 2010 Nov;39(6):466-71. doi: 10.3109/03009741003742797. Epub 2010 Jun 21.'}, {'pmid': '32039399', 'type': 'BACKGROUND', 'citation': 'Hallsworth K, Adams LA. Lifestyle modification in NAFLD/NASH: Facts and figures. JHEP Rep. 2019 Nov 5;1(6):468-479. doi: 10.1016/j.jhepr.2019.10.008. eCollection 2019 Dec.'}, {'pmid': '17911352', 'type': 'BACKGROUND', 'citation': 'Harrison SA, Day CP. Benefits of lifestyle modification in NAFLD. Gut. 2007 Dec;56(12):1760-9. doi: 10.1136/gut.2006.112094. Epub 2007 Oct 2. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPrevious studies suggested a significant association between hyperuricemia and MAFLD and that hyperuricemia plays a causal role in the development of MAFLD.\n\nXanthine 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.', 'detailedDescription': '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.\n\nPrimary Outcome: Regression of hepatic steatosis. Secondary Outcome: Improvement of Serum uric acid and incidence of hepatotoxicity.\n\nStudy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-65.\n* Males and Females\n* Metabolic syndrome according to the NCEP ATP III definition \\[13\\]: present of three or more of the following five criteria are met:\n\n * 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\n * Blood pressure over 130/85 mmHg,\n * Basting triglyceride (TG) level over 150 mg/dl,\n * Fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women),\n * Fasting blood sugar over 100 mg/dl.\n* Serum uric acid levels of \\> 420μmol/L (\\>7 mg/dL) in men and \\>360 μmol/L (\\>6 mg/dL) women.\n\nExclusion Criteria:\n\n* Renal insufficiency defined by serum creatinine \\> 2.0 mg/dl.\n\n * Patients with obvious abnormal liver function: serum transaminase (ALT, AST, one of them) exceed 2 times the upper limit of normal reference value.\n * Have a history of viral hepatitis, or serological examination suggests hepatitis virus infection, or have a history of other liver diseases.\n * Complementation with diabetes, or fasting blood glucose \\>7.8mmol/L, or HbA1c \\>7.5%.\n * Severe hypertension, blood pressure ≥ 160/100 mmHg.\n * A history of allergy to febuxostat and allopurinol; in the acute active phase of gout.\n * Drinking equivalent to alcohol intake ≥30g/d(male), ≥20g/d(female).\n * Complicated coronary heart disease.\n * Cardiac dysfunction (cardiac function grade 2 or above).\n * Patients with asthma and other respiratory diseases.\n * Intestinal diseases such as inflammatory bowel disease.\n * Any history of systemic malignancy in the past 5 years.\n * Use of uric-lowering drugs in the 4 weeks before screening: febuxostat, allopurinol, benzbromarone.\n * Morbid obesity (BMI\\>37.5kg/m2).\n * Triglyceride ≥5.0 mmol/L was found to be significantly abnormal in baseline examination.\n * had received systemic hormone or immunosuppressive therapy within 3 months prior to screening or expected to receive hormone or immunosuppressive therapy in the future.\n * 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.\n\nOther drugs that may affect liver fat content were taken within 4 weeks before screening.\n\n* Women who are lactating or pregnant.'}, 'identificationModule': {'nctId': 'NCT05474560', 'briefTitle': 'Febuxostat Versus Allopurinol on Hepatic Steatosis in MAFLD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Allopurinol Versus Febuxostat: A New Approach for Management of Hepatic Steatosis in Metabolic-Associated Fatty Liver Disease', 'orgStudyIdInfo': {'id': 'Febuxostat versus allopurinol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allopurinol group', 'description': 'Allopurinol (100 mg/day) plus lifestyle intervention', 'interventionNames': ['Drug: Allopurinol (100 mg/day) plus lifestyle intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Febuxostat group', 'description': 'Febuxostat (40 mg/day) plus lifestyle intervention', 'interventionNames': ['Drug: Febuxostat 40 mg plus lifestyle intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lifestyle intervention', 'description': 'diet and exercise', 'interventionNames': ['Behavioral: Life style intervention']}], 'interventions': [{'name': 'Allopurinol (100 mg/day) plus lifestyle intervention', 'type': 'DRUG', 'otherNames': ['Allopurinol group'], 'description': 'participants accept allopurinol treatment (100 mg, once a day, orally). Behavioral: lifestyle intervention According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).', 'armGroupLabels': ['Allopurinol group']}, {'name': 'Febuxostat 40 mg plus lifestyle intervention', 'type': 'DRUG', 'otherNames': ['Febuxostat group'], 'description': 'participants accept Febuxostat treatment (100 mg, once a day, orally). Behavioral: lifestyle intervention According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).', 'armGroupLabels': ['Febuxostat group']}, {'name': 'Life style intervention', 'type': 'BEHAVIORAL', 'description': 'According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).', 'armGroupLabels': ['lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Hepatology and tropical medicine research institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sarah Ma Zaki, Ass.Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}