Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 5:35 AM
Study NCT ID:
NCT05308160
Status:
UNKNOWN
Last Update Posted:
2022-04-01
First Post:
2022-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Outcome Measure', 'timeFrame': '6 months', 'description': 'Patients who meet all inclusion criteria and none of the exclusion criteria and are not screen failures for reasons listed above will be randomized in a 1:1 ratio to either receive 10 mg per day dapagliflozin or enter control group at Visit 2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatty Liver']}, 'descriptionModule': {'briefSummary': 'This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \\& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nFor inclusion in the study patients should fulfil the following criteria:\n\n1. Provision of informed consent prior to the time of registration.\n2. Aged 20-74 years male or female who are diagnosed with NAFLD and FibroScan shows CAP score ≥ 252 dB/m (≥Steatosis grade 2).\n\n3.30 or more mL/min/1.73 m2 of estimated glomerular filtration rate 4.Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 1 month after the last dose of IP to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.\n\n5.Subjects who are blood donors should not donate blood during the study and for 1 month following their last dose of IP.\n\nExclusion criteria\n\nSubjects should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Viral hepatitis or other types of liver disorder (e.g. drug-induced or autoimmune hepatitis).\n2. Alcohol consumption above recommended limits (male: more than 30g/ day; female: more than 20g/day converting to ethanol).\n3. Serious liver dysfunction (Child-Pugh B or C).\n4. History of any other malignancy within 1 years (with the exception of successfully treated non-melanoma skin cancers).\n5. Patients with a known hypersensitivity to investigator product (IP).\n6. Participation in another clinical trial within the previous 30 days or involvement in the planning and/or conduct of the study.\n7. Previous enrolment or randomisation in the present study.\n8. Active gallbladder diseases\n9. For women is currently pregnant (confirmed with positive pregnancy test) or breast feeding.'}, 'identificationModule': {'nctId': 'NCT05308160', 'briefTitle': 'A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '202104098MIPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin', 'description': 'This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease.', 'interventionNames': ['Drug: Dapagliflozin 10Mg Tab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-used drug', 'description': 'This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin 10Mg Tab', 'type': 'DRUG', 'description': 'This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \\& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \\& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.', 'armGroupLabels': ['Non-used drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100229', 'city': 'Taipei', 'state': 'Zhongzheng Dist.', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tzu Meng Weng', 'role': 'CONTACT', 'email': 'wengmengtzu@gmail.com', 'phone': '+886-2312-3456', 'phoneExt': '66579'}], 'facility': 'NTUH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tzu Meng Weng', 'role': 'CONTACT', 'email': 'wengmengtzu@gmail.com', 'phone': '+886-2312-3456', 'phoneExt': '66579'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}