Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-06 @ 3:39 AM
Study NCT ID:
NCT05785793
Status:
RECRUITING
Last Update Posted:
2023-03-28
First Post:
2023-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoimmune Hepatitis Cohort in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019693', 'term': 'Hepatitis, Autoimmune'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples and liver biopsy specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-26', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transplant free survival', 'timeFrame': 'From baseline to 60 months after baseline', 'description': 'Time to the first occurrence of liver transplant or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Liver-related death', 'timeFrame': 'From baseline to 60 months after baseline', 'description': 'Time to the first occurrence of liver transplant or death from liver-related cause'}, {'measure': 'Biochemical response', 'timeFrame': 'From baseline to 60 months after baseline', 'description': 'Proportion of patients who achieve complete biochemical response (normalisation of serum transaminases and immunoglobulin G below the ULN)'}, {'measure': 'Remission', 'timeFrame': 'From baseline to 60 months after baseline', 'description': 'Proportion of patients who achieve remission (hepatitis activity index\\<4/18)'}, {'measure': 'Complications', 'timeFrame': 'From baseline to 60 months after baseline', 'description': 'Occurrence of variceal hemorrhage, ascites, jaundice, encephalopathy and hepatocellular carcinoma'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Hepatitis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to describe the clinical features and long-term prognosis in patients diagnosed with autoimmune hepatitis (AIH) in China and assess the effectiveness and safety of AIH treatment options in a real-world setting.', 'detailedDescription': 'Autoimmune hepatitis (AIH) is a chronic autoimmune liver disease that causes liver inflammation and necrosis, ultimately leading to cirrhosis and liver failure. Although relatively rare, the prevalence of AIH in China has been increasing in recent years, highlighting its significance as a public health issue. However, due to the wide variability in the clinical presentation and outcomes of AIH, diagnosing and managing the disease can be challenging. Moreover, our understanding of the epidemiology, clinical features, diagnosis, and treatment of AIH in China is still limited.\n\nTo address this gap in knowledge, the investigators are conducting the Chinese AIH Cohort study, which collects data from approximately 20 sites across China on treatment progress and success in clinical routine. The study aims to evaluate the effectiveness and safety/tolerability of different AIH treatment options, including standard therapy, and second and third-line treatment options. The investigators also record the long-term prognosis of patients with AIH, tracking whether they achieve remission, require liver transplantation, or experience mortality. Risk factors associated with long-term prognosis and survival will be analyzed to provide insights that can improve the diagnosis, treatment, and management of AIH in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients diagnosed as AIH in medical centers and outpatient clinics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 14 years\n* Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria\n* Availability of all following essential parameters at the initial diagnosis of AIH: including alanine transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, immunoglobulin G, and platelet count\n* Provide informed consent\n\nExclusion Criteria:\n\n* Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, immunoglobulin G 4-related cholangitis\n* Have an active infection with hepatitis B virus, hepatitis C virus, hepatitis delta virus, HIV, cytomegalovirus, or Epstein-Barr virus\n* Have a concomitant diagnosis of hepatocellular carcinoma or other malignant diseases before the diagnosis of AIH\n* Considered ineligible to the enrollment in the clinical study by the researcher'}, 'identificationModule': {'nctId': 'NCT05785793', 'acronym': 'CAMERA', 'briefTitle': 'Autoimmune Hepatitis Cohort in China', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China', 'orgStudyIdInfo': {'id': 'AIH-CH'}}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Xiao', 'role': 'CONTACT', 'email': 'xiaoxiao@renji.com', 'phone': '021-68383104'}], 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiao Xiao, MD', 'role': 'CONTACT', 'email': 'xiaoxiao@renji.com', 'phone': '021-68383104'}], 'overallOfficials': [{'name': 'Xiong Ma, MD,PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Gastroenterology and Hepatology, Renji Hospital', 'investigatorFullName': 'maxiong', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}