Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT01533051
Status:
UNKNOWN
Last Update Posted:
2012-05-08
First Post:
2012-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Initially, 30ml of heparinized peripheral blood will be obtained from each subjects. After then, 10ml of heparinized peripheral blood will be additionaly obtained at every 3 months follow-up visit.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-07', 'studyFirstSubmitDate': '2012-02-07', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response after stopping anti-viral treatment', 'timeFrame': 'Up to 3 years', 'description': 'The proportion of patients with sustained virological response after stopping anti-viral treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic hepatitis B', 'Nucleos(t)ide analogue', 'Antiviral treatment', 'Korea'], 'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guideline by the Asian Pacific Association for the Study of the Liver (APASL) in Korea.', 'detailedDescription': 'In the recommendation by the Asian PAcific Association for the Study of the Liver(APASL), antiviral drug is recommended to stop when HBeAg seroconversion has developed for more than 6 months among HBeAg-positive patietns. For HBeAg-negative patients, the APASL consensus recommended stopping anti-viral treatment when HBV DNA remained undetectable for three separates occasion 6 months apart. Nontheless, approximately 25% to 50% of the patients still develop hepatitis relapse after stopping anti-viral therapy even if these recommendations are followed. In this study, the investigators aimed to investigated the off-treatment sustained response in chronic hepatitis B parients following the stopping anti-viral treatment guideline in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic Hepatitis B patients under anti-viral therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 20 years old\n* Chronic hepatitis B patients under anti-viral therapy\n\n 1. In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months\n 2. In HBeAg-negative patient; if undetectable HBV DNA has been documented on three separate occasions 6 months apart\n\nExclusion Criteria:\n\n* Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia\n* Patients who suffered from other chronic medical condition'}, 'identificationModule': {'nctId': 'NCT01533051', 'briefTitle': 'Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'Quit Anti-viral therapy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic hepatitis B'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hana Park, MD', 'role': 'CONTACT', 'email': 'PHN223@yuhs.ac', 'phone': '02-2228-1931'}, {'name': 'Kwang-Hyub Han, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Do Young Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jun Yong Park, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seung Up Kim, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hana Park, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Young Eun Chon, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sang Hoon Ahn', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hana Park, MD', 'role': 'CONTACT', 'email': 'PHN223@yuhs.ac', 'phone': '02-2228-1931'}], 'overallOfficials': [{'name': 'Sang Hoon Ahn, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Internal Medicine, Yonsei Universtiy College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sang Hoon Ahn', 'investigatorAffiliation': 'Yonsei University'}}}}