Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-27 @ 1:47 PM
Study NCT ID:
NCT01768195
Status:
UNKNOWN
Last Update Posted:
2017-01-10
First Post:
2013-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C413685', 'term': 'entecavir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-08', 'studyFirstSubmitDate': '2013-01-09', 'studyFirstSubmitQcDate': '2013-01-12', 'lastUpdatePostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis', 'timeFrame': 'from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy'}], 'secondaryOutcomes': [{'measure': 'the incidence of hepatitis B virus virological response', 'timeFrame': 'from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy'}, {'measure': 'the incidence of hepatitis B virus serological response', 'timeFrame': 'from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy'}, {'measure': 'the incidence of hepatitis B virus maintained response', 'timeFrame': 'from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy'}, {'measure': 'the incidence of hepatitis B virus sustained response', 'timeFrame': 'from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy'}, {'measure': 'the incidence of hepatitis B virus relapse and relapse related hepatitis', 'timeFrame': 'from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lymphoma', 'Hepatitis B Virus', 'Therapeutic Uses', 'Antiviral Agents', 'rituximab'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.', 'detailedDescription': 'HBsAg Positive lymphoma patients are treated with entecavir when they receive rituximab-based immunochemotherapy. Entecavir 0.5mg daily is administrated from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* treatment-naive patients with B-cell lymphoma\n* HBsAg positive at baseline\n* treated with rituximab-based immunochemotherapy\n* life expectancy of more than 3 months\n\nExclusion Criteria:\n\n* younger than 18 years old\n* HBsAg negative at baseline\n* pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01768195', 'briefTitle': 'Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy', 'orgStudyIdInfo': {'id': 'PKU-2012111304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Entecavir prophylaxis', 'description': 'Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of immunochemotherapy and/or chemotherapy, and will be continued until 12 months after completion of the immunochemotherapy and/or chemotherapy.', 'interventionNames': ['Drug: Entecavir prophylaxis']}], 'interventions': [{'name': 'Entecavir prophylaxis', 'type': 'DRUG', 'otherNames': ['Baraclude'], 'description': 'Entecavir 0.5mg daily from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.\n\nIn patients with low load of hepatitis B virus DNA(≤2000 IU/ml), rituximab will be administrated at the beginning of entecavir prophylaxis. And in patients with high load of hepatitis B virus DNA(\\>2000 IU/ml), rituximab will be administrated when hepatitis B virus DNA decreased to the level of 2000 IU/ml after entecavir prophylaxis.', 'armGroupLabels': ['Entecavir prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Zhu', 'role': 'CONTACT', 'email': 'zj@bjcancer.org'}, {'name': 'Yuqin Song', 'role': 'CONTACT', 'email': 'songyuqin622@sina.com'}, {'name': 'Jun Zhu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Cancer Hospital & Institute', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weijing Zhang', 'role': 'CONTACT'}, {'name': 'Weijing Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "307 Hospital of the Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liping Ye', 'role': 'CONTACT'}, {'name': 'Liping Ye', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "309 Hospital of the Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingbo Wang', 'role': 'CONTACT'}, {'name': 'Jingbo Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aerospace Central Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Xue', 'role': 'CONTACT'}, {'name': 'Mei Xue', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Air Force General Hospital of the Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Liu', 'role': 'CONTACT'}, {'name': 'Hui Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuankai Shi', 'role': 'CONTACT'}, {'name': 'Yuankai Shi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Institute & Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoxiong Wu', 'role': 'CONTACT'}, {'name': 'Xiaoxiong Wu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "First Hospital affiliated to General Hospital of the Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Yu', 'role': 'CONTACT'}, {'name': 'Li Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "General Hospital of Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daobin Zhou', 'role': 'CONTACT'}, {'name': 'Daobin Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hanyun Ren', 'role': 'CONTACT'}, {'name': 'Hanyun Ren', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojun Huang', 'role': 'CONTACT'}, {'name': 'Xiaojun Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyan Ke', 'role': 'CONTACT'}, {'name': 'Xiaoyan Ke', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Zhu', 'role': 'CONTACT', 'email': 'zj@bjcancer.org'}, {'name': 'Yuqin Song', 'role': 'CONTACT', 'email': 'songyuqin622@sina.com'}], 'overallOfficials': [{'name': 'Jun Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Peking University Cancer Hospital & Institute', 'investigatorFullName': 'Jun Zhu', 'investigatorAffiliation': 'Peking University'}}}}