Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-02 @ 9:42 AM
Study NCT ID:
NCT04028856
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study of Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007372', 'term': 'Interferons'}], 'ancestors': [{'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-20', 'studyFirstSubmitDate': '2019-07-20', 'studyFirstSubmitQcDate': '2019-07-20', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of disappearance of HBsAg', 'timeFrame': 'after 48 weeks of treatment', 'description': 'Rate of disappearance of HBsAg after 48 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'HBeAg seroconversion rate', 'timeFrame': 'at the treatment of 48 weeks', 'description': 'Treatment of 48 weeks HBeAg seroconversion rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic hepatitis B', 'interferon', 'intermittent', 'HBV', 'HBsAg', 'HBV DNA'], 'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '36110295', 'type': 'DERIVED', 'citation': 'Li M, Xie S, Bi X, Sun F, Zeng Z, Deng W, Jiang T, Lin Y, Yang L, Lu Y, Zhang L, Yi W, Xie Y. An optimized mode of interferon intermittent therapy help improve HBsAg disappearance in chronic hepatitis B patients. Front Microbiol. 2022 Aug 30;13:960589. doi: 10.3389/fmicb.2022.960589. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This study was a retrospective clinical observational cohort study. All patients with chronic hepatitis B (CHB) whose HBsAg decreased by less than 10% were treated continuously with interferon in the Department of Hepatology, Beijing Ditan Hospital, Beijing Medical University, Beijing Capital University, 2008.10-2017.4. The total interferon treatment time of the enrolled subjects was 48 weeks. The subjects were randomly divided into the following two observation cohorts: 1) patients with chronic hepatitis B treated with continuous interferon for 48 weeks; 2) intermittent interferon For 48 weeks of treatment for patients with chronic hepatitis B, the interferon treatment interval was 3 months. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical markers, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline) and during treatment. The primary outcome measure was the rate at which HBsAg disappeared at 48 weeks of treatment. The secondary evaluation index was the 48-week HBeAg seroconversion rate. To investigate the efficacy, influencing factors and safety of interferon intermittent treatment of chronic hepatitis B.', 'detailedDescription': 'This study was a retrospective clinical observational cohort study. All patients with chronic hepatitis B (CHB) whose HBsAg decreased by less than 10% were treated continuously with interferon in the Department of Hepatology, Beijing Ditan Hospital, Beijing Medical University, Beijing Capital University, 2008.10-2017.4. The total interferon treatment time of the enrolled subjects was 48 weeks. The subjects were randomly divided into the following two observation cohorts: 1) patients with chronic hepatitis B treated with continuous interferon for 48 weeks; 2) intermittent interferon For 48 weeks of treatment for patients with chronic hepatitis B, the interferon treatment interval was 3 months. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical markers, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline) and during treatment. The primary outcome measure was the rate at which HBsAg disappeared at 48 weeks of treatment. The secondary evaluation index was the 48-week HBeAg seroconversion rate. To investigate the efficacy, influencing factors and safety of interferon intermittent treatment of chronic hepatitis B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis B (CHB) with a reduction in HBsAg of less than 10% were treated with interferon for 6 months. All patients with chronic hepatitis B were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with chronic hepatitis B meet the diagnostic criteria of China Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)\n\nExclusion Criteria:\n\n* coinfection with other viruses including HCV, HDV, and HIV;\n* syphilis antibody positive;\n* co-exist other liver diseases including alcoholic liver disease, metabolic liver disease, fatty liver, drug induce liver injury, and autoimmune liver disease;\n* complication of cirrhosis or liver cancer.'}, 'identificationModule': {'nctId': 'NCT04028856', 'briefTitle': 'Cohort Study of Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Ditan Hospital'}, 'officialTitle': 'Cohort Study on Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'DTXY019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Continuous interferon treatment group', 'description': 'Patients with chronic hepatitis B treated with continuous interferon for 48 weeks', 'interventionNames': ['Drug: interferon']}, {'label': 'Intermittent interferon treatment group', 'description': 'patients with chronic hepatitis B treated with intermittent interferon for 48 weeks, in which interferon therapy was intermittent for 3 months', 'interventionNames': ['Drug: interferon']}], 'interventions': [{'name': 'interferon', 'type': 'DRUG', 'description': 'Chronic hepatitis B patients were treated with interferon for 48 weeks', 'armGroupLabels': ['Continuous interferon treatment group', 'Intermittent interferon treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'liver disease center, Beijing Ditan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yao Xie, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of hepatology Division 2, Beijing Ditan Hospital, Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of liver diseases center', 'investigatorFullName': 'Yao Xie', 'investigatorAffiliation': 'Beijing Ditan Hospital'}}}}