Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-10 @ 1:35 AM
Study NCT ID:
NCT02167503
Status:
UNKNOWN
Last Update Posted:
2014-06-19
First Post:
2014-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2014-06-17', 'studyFirstSubmitQcDate': '2014-06-17', 'lastUpdatePostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative rates of hepatocellular carcinoma', 'timeFrame': 'Year 5'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis B from hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged over 30 (inclusive) years of old\n* Patients has a history of diagnosis of chronic hepatitis B (ie. HBsAg positive for more than 6 months)\n* For patients with HBsAg positive, patients should be undergoing anti-viral treatment\n* For patients with HBsAg negative, a documented evidence of previous anti-viral treatment should be provided.\n* Life expectancy is more than 1 year\n* Good treatment compliance.\n\nExclusion Criteria:\n\n* Patients has a history of diagnosis of hepatocellular carcinoma\n* Patients with Child Pugh C\n* Coinfected with HCV, HDV and HIV\n* Suffering from other serious disease\n* Taking part in other clinical trial'}, 'identificationModule': {'nctId': 'NCT02167503', 'briefTitle': 'Observational Study on Patients With Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'A Retrospective-prospective Observational Study to Evaluate the Effect of Anti-viral Treatment on the Long-term Outcome in Patients With Chronic Hepatitis B (SEARCH-B Study)', 'orgStudyIdInfo': {'id': 'MOH-08'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Cheng, MD', 'role': 'CONTACT'}, {'name': 'Jun Cheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Ditan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Ma, MD', 'role': 'CONTACT', 'phone': '13651096128'}, {'name': 'hong ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Friendship Hospital Attached to the Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'XinYue Chen, MD', 'role': 'CONTACT', 'phone': '13911212398'}, {'name': 'XinYue Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BeiJing YouAn Hospital ,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanyan Yu, MD', 'role': 'CONTACT', 'phone': '13901194223'}, {'name': 'Yanyan Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of infectious disease, First Hospital of Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lai Wei, MD', 'role': 'CONTACT'}, {'name': 'Lai Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hao Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "People's Hospital of Beijing University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinlin Hou, MD', 'role': 'CONTACT'}, {'name': 'Jinlin Hou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of infectious disease, Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ZhiLiang Gao, MD', 'role': 'CONTACT', 'phone': '13902263533'}, {'name': 'ZhiLiang GAo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Third Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Ning', 'role': 'CONTACT', 'phone': '13971521450'}, {'name': 'Qin Ning', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'DeMing Tan, MD', 'role': 'CONTACT', 'phone': '13875986817'}, {'name': 'DeMing Tan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xiangya Hospital Central-South Univrsity', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'JunQi Niu, MD', 'role': 'CONTACT', 'phone': '13756661205'}, {'name': 'JunQi Niu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Hospital .Jilin Unniversity', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'XiaoGuang Dou, MD', 'role': 'CONTACT', 'phone': '13898867074'}, {'name': 'XiaoGuang Dou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ShengJing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'GuangFeng Shi, MD', 'role': 'CONTACT', 'phone': '13817780666'}, {'name': 'GuangFeng Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huashan Hospital，Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qing Xie, MD', 'role': 'CONTACT', 'phone': '13651804273'}, {'name': 'Qing Xie', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'JiFang Sheng, MD', 'role': 'CONTACT', 'phone': '13600519200'}, {'name': 'JiFang Sheng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of College of Medicine ，Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jinlin Hou, MD', 'role': 'CONTACT', 'email': 'jlhousmu@163.com', 'phone': '86-20-61641941'}, {'name': 'Jian Sun, MD', 'role': 'CONTACT', 'email': 'doctorsunjian@163.com', 'phone': '86-20-62787432'}], 'overallOfficials': [{'name': 'Jinlin Hou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Family Planning Commission, P.R.China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}