Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT04617561
Status:
UNKNOWN
Last Update Posted:
2021-03-22
First Post:
2020-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019693', 'term': 'Hepatitis, Autoimmune'}, {'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical remission', 'timeFrame': 'up to 12 months', 'description': 'The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after treatment, per treatment group.'}], 'secondaryOutcomes': [{'measure': 'Partial remission', 'timeFrame': 'up to 12 months', 'description': 'Partial remission, defined as ALT or AST serum levels \\>1x Upper Limit of Normal (ULN) and \\<2x ULN'}, {'measure': 'Minimal response', 'timeFrame': 'up to 12 months', 'description': 'Minimal response, defined as decrease of ALT or AST serum levels but still \\>2x ULN'}, {'measure': 'Treatment failure', 'timeFrame': 'up to 12 months', 'description': 'defined as no improvement or increase of ALT or AST serum levels'}, {'measure': 'ALT,AST,IgG', 'timeFrame': 'baseline and month 3,6,12', 'description': 'serum ALT,AST and IgG levels'}, {'measure': 'percentage of immune cells', 'timeFrame': 'baseline and month 12', 'description': 'percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT'}, {'measure': 'Side-effects', 'timeFrame': 'up to 12 months', 'description': 'Drug related side-effects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucocorticoid', 'Ursodeoxycholic Acid'], 'conditions': ['Hepatitis, Autoimmune', 'Primary Biliary Cholangitis']}, 'descriptionModule': {'briefSummary': 'A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged 18-75 years;\n2. The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 3xULN \\< ALT \\< 5xULN or 3xULN \\< AST \\< 5xULN or 1.3xULN \\< IgG \\< 2xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;\n3. Agreed to participate in the trial, and assigned informed consent.\n\nExclusion Criteria:\n\n1. The presence of hepatitis A, B, C, D, or E virus infection;\n2. Patients with presence of cirrhosis;\n3. Patients with presence of fulminant liver failure;\n4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease; Pregnant and breeding women and women of childbearing age in need of reproduction;\n5. Severe disorders of other vital organs, such as severe heart failure, cancer;\n6. Parenteral administration of blood or blood products within 6 months before screening;\n7. Recent treatment with drugs having known liver toxicity;\n8. Taken part in other clinic trials within 6 months before enrollment.\n9. patients with contraindications of glucocorticoid"}, 'identificationModule': {'nctId': 'NCT04617561', 'briefTitle': 'Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial', 'orgStudyIdInfo': {'id': 'PBC With AIH Features II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ursodeoxycholic Acid group', 'description': 'Ursodeoxycholic Acid 13-15mg/kg/d', 'interventionNames': ['Drug: Ursodeoxycholic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Ursodeoxycholic Acid+Low Dose Glucocorticoid group', 'description': 'Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period', 'interventionNames': ['Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)']}], 'interventions': [{'name': 'Ursodeoxycholic acid', 'type': 'DRUG', 'otherNames': ['UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)'], 'description': 'Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)', 'armGroupLabels': ['Ursodeoxycholic Acid group']}, {'name': 'Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)', 'type': 'DRUG', 'otherNames': ['Medrol（4mg*30,pfizer ltalia srl)'], 'description': 'Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)', 'armGroupLabels': ['Ursodeoxycholic Acid+Low Dose Glucocorticoid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Yang, MD', 'role': 'CONTACT', 'email': 'yangli_hx@scu.edu.cn', 'phone': '+86 18980601276'}, {'name': 'Chen Huang', 'role': 'CONTACT', 'email': 'huangchen0323@163.com', 'phone': '+86 18328089415'}, {'name': 'Chen Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Li Yang', 'investigatorAffiliation': 'West China Hospital'}}}}