Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-18 @ 6:55 PM
Study NCT ID:
NCT02491905
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-02', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-07-02', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in Alanine Transaminase (ALT)', 'timeFrame': '8 and 12 week'}, {'measure': 'Changes in Asparate Transaminase (AST)', 'timeFrame': '8 and 12 week'}, {'measure': 'Changes in cholesterol', 'timeFrame': '8 and 12 week'}, {'measure': 'Changes in triglyceride', 'timeFrame': '8 and 12 week'}, {'measure': 'Changes in free fatty acid', 'timeFrame': '8 and 12 week'}, {'measure': 'Changes in insulin resistance', 'timeFrame': '8 and 12 week'}, {'measure': 'Changes in Body Mass Index (BMI)', 'timeFrame': '8 and 12 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low dose, high dose, and placebo control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 19 and 75\n2. Non-alcoholic fatty liver disease patient\n\n * Diagnosed by abdomen ultrasonic examination\n * Non-drinker (alcohol intake per week : female-under 140g, male-under 210g)\n3. ALT or AST higher than normal range (not over 4 times normal range)\n4. Voluntary agreement and enrollment\n\nExclusion Criteria:\n\n1. The ratio of AST/ALT over 2\n2. Type I diabetes mellitus patient\n3. Any dysfunction of liver besides non-alcoholic fatty liver disease\n4. Alcoholic fatty liver disease patient or heavy drinker\n5. Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months\n6. Patient taking any product which affects the BMI or hyperlipidemia\n7. Any dyscrasia that investigator considers not to appropriate for this study\n8. Bariatric surgery within 6 months\n9. Any disease which is able to change the distribution of cytokines\n10. Any treatment that affects liver functions within 1 month\n11. Participation in other clinical trials within 3 months\n12. Person who can not use MRS\n13. Pregnancy or breast-feeding\n14. Fertile women who do not use contraception\n15. Sensitive to the investigational product\n16. Any conditions that the investigator considers not to appropriate for this study'}, 'identificationModule': {'nctId': 'NCT02491905', 'briefTitle': 'Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Huons Co., Ltd.'}, 'officialTitle': 'Phase 2 Study to Assess Safety and Efficacy of HL Tablet on Reducing Hepatic Fat in Non-alcoholic Fatty Liver Disease Patients', 'orgStudyIdInfo': {'id': '12-HS-HP-09-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low dose HL tablet', 'description': 'HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal', 'interventionNames': ['Drug: HL tablet']}, {'type': 'EXPERIMENTAL', 'label': 'high dose HL tablet', 'description': 'HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal', 'interventionNames': ['Drug: HL tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'Placebo by oral administration, twice daily in an hour after meal', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HL tablet', 'type': 'DRUG', 'armGroupLabels': ['high dose HL tablet', 'low dose HL tablet']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '426791', 'city': 'Ansan', 'state': 'Kyeonggi-do', 'country': 'South Korea', 'facility': 'Huons', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huons Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}