Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04727320
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2020-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2021-08-02', 'unreleaseDate': '2021-08-06'}, {'resetDate': '2021-09-03', 'releaseDate': '2021-08-09'}], 'estimatedResultsFirstSubmitDate': '2021-08-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031655', 'term': 'ursodoxicoltaurine'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-07', 'studyFirstSubmitDate': '2020-12-25', 'studyFirstSubmitQcDate': '2021-01-24', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver biopsy', 'timeFrame': 'up to 24 weeks', 'description': 'Synthesis of liver extracellular matrix（Synthesis, degradation）'}], 'secondaryOutcomes': [{'measure': 'Liver ultrasound', 'timeFrame': 'up to 24 weeks', 'description': 'Liver parenchymal echo（Normal, dense, thickened）'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'This study is a prospective study. We signed an informed consent form with patients with liver fibrosis and took tauroursodeoxycholic acid orally for half a year. After half a year, liver biopsy was performed using histopathology, immunohistochemistry, and polymerase chain reaction, Western blotting method was used to determine the expression level of fibrosis-related markers to verify the effect of taurodeoxycholic acid on patients with liver fibrosis.', 'detailedDescription': 'Tauroursodeoxycholic acid is an effective component of bear bile, which has obvious curative effects in the treatment of gallstones and liver diseases. In recent years, the research field of tauroursodeoxycholic acid has been very active, and its chemical synthesis has also attracted much attention. The usage is swallowing with water before going to bed at night. It must be taken regularly, one capsule at a time (250mg), once a day. After 6 months of continuous use, liver biopsy was performed after 6 months. Telling the patient to swallow with water before going to bed at night. It must be taken regularly, one capsule at a time (250mg), once a day. After 6 months of continuous use, liver B-ultrasound biopsy was performed to observe the effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of liver cirrhosis and liver fibrosis in patients requiring medical treatment.\n\nExclusion Criteria:\n\n* Patients with end-stage cirrhosis, liver failure, etc. who need liver transplantation.'}, 'identificationModule': {'nctId': 'NCT04727320', 'briefTitle': 'The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.', 'orgStudyIdInfo': {'id': 'Ling Lv'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient+TUDCA', 'interventionNames': ['Drug: Tauroursodeoxycholic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'patient+placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tauroursodeoxycholic acid', 'type': 'DRUG', 'description': 'Oral TUDCA, once a day, one tablet (250mg) at a time for 6 months', 'armGroupLabels': ['patient+TUDCA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo, once a day, one tablet at a time for 6 months', 'armGroupLabels': ['patient+placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-08-02', 'type': 'RELEASE'}, {'date': '2021-08-06', 'type': 'UNRELEASE'}, {'date': '2021-08-09', 'type': 'RELEASE'}, {'date': '2021-09-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'The First Affiliated Hospital with Nanjing Medical University'}}}}