Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT06865859
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Cell Landscape of HBV-related Acute-on-chronic Liver Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and liver tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 days, 90 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HBV Related Acute-on-chronic Liver Failure']}, 'descriptionModule': {'briefSummary': 'This study aimed to profile the peripheral blood immune cells of patients with HBV related acute-on-chronic liver failure using single-cell RNA sequencing to reveal the immunopathological mechanisms of HBV related acute-on-chronic liver failure.', 'detailedDescription': 'Acute-on-chronic liver failure (ACLF) is a complex clinical syndrome characterized by acute deterioration of liver function in patients with chronic liver disease, exhibiting liver and extrahepatic organ failure and a high short-term mortality. Immune imbalance plays an important role in the progression of HBV-related ACLF. Further investigation of the immune cell characteristics of HBV-related ACLF is helpful to understand its pathogenesis, and may provide reference for the effective therapeutic agent. Single-cell RNA sequencing (scRNA-seq) is the quantitative analysis of transcription at the single-cell level, which could provide systematic analyses of transcriptomic profiles, infer cell-cell interactions. This study will combine single cell transcriptomics and molecular biological experiment to elucidate the immunopathological cell states associated with HBV-related chronic liver disease vs. ACLF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is patients with chronic hepatitis B，HBV related liver cirrhosis，HBV related acute-on-chronic hepatic dysfunction and HBV related acute-on-chronic liver failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAcute liver failure is a well-defned medical emergency which is defned as a severe liver injury, leading to coagulation abnormality usually with an INR ≥ 1.5, and any degree of mental alteration (encephalopathy) in a patient without pre-existing liver disease and with an illness of up to 4 weeks duration\n\nExclusion Criteria:\n\n* Associated with other types of hepatitis virus infection or HIV infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② Suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ Patients with incomplete data and patients unable to participate in the experiment.'}, 'identificationModule': {'nctId': 'NCT06865859', 'briefTitle': 'Single Cell Landscape of HBV-related Acute-on-chronic Liver Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Single-cell Landscape of Immunological Responses in Patients with Hepatitis B Virus-related Acute-on-chronic Liver Failure', 'orgStudyIdInfo': {'id': 'KYLL-202310-036'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Hepatitis B'}, {'label': 'HBV related liver cirrhosis'}, {'label': 'HBV related acute-on-chronic hepatic dysfunction'}, {'label': 'HBV related acute-on-chronic liver failure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu-Chen Fan', 'role': 'CONTACT', 'email': 'fanyuchen@sdu.edu.cn', 'phone': '0086+053182169593'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yu-Chen Fan', 'role': 'CONTACT', 'email': 'fanyuchen@sdu.edu.cn', 'phone': '0086+053182169593'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}