Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02287857
Status:
UNKNOWN
Last Update Posted:
2019-03-19
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-16', 'studyFirstSubmitDate': '2014-10-30', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compared with baseline, decline of serum HBV-DNA in the value', 'timeFrame': '48 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '34222435', 'type': 'DERIVED', 'citation': 'Chen XF, Fan YN, Si CW, Yu YY, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Xu JH. Tenofovir disoproxil fumarate in Chinese chronic hepatitis B patients: Results of a multicenter, double-blind, double-dummy, clinical trial at 96 weeks. World J Clin Cases. 2021 Jun 26;9(18):4690-4699. doi: 10.12998/wjcc.v9.i18.4690.'}, {'pmid': '31415381', 'type': 'DERIVED', 'citation': 'Liang RY, Xu JH, Si CW, Wang S, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Yu YY. A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48. Medicine (Baltimore). 2019 Aug;98(33):e16778. doi: 10.1097/MD.0000000000016778.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B\n* Aged 18 to 65 years old，male or female\n* Patients with previously HBsAg-positive lasted for 6months at least：HBeAg-positive subjects, HBV-DNA\\> 105copies/ml； HBeAg-negative subjects, HBV-DNA\\> 104copies/ml.\n* 2 times the upper normal limit (2 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.\n* Total serum bilirubin (TBIL) ≤ 2.5 × ULN.\n* Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).\n* WBC ≥ 3.5 × 109 / L, PLT ≥ 80 × 109 / L, serum albumin (ALB)≥ 35 g / L.\n* Creatinine (Cr) ≤ 1× ULN，serum phosphate was normal.\n* Patients signed an informed consent form and compliance was good.\n\nExclusion Criteria:\n\n* Patients were infected with other viruses as HAV, HCV, HEV, HIV etc.\n* Patients with cirrhosis or liver cancer.\n* Pregnant woman, lactating women .\n* Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.\n* Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.\n* Patients allergic for study drug.'}, 'identificationModule': {'nctId': 'NCT02287857', 'briefTitle': 'Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'CTTQ-TDF-V4.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Domestic Tenofovir Disoproxil Fumarate Tablets', 'interventionNames': ['Drug: Domestic Tenofovir Disoproxil Fumarate Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tenofovir Disoproxil Fumarate Tablets of Gilead', 'interventionNames': ['Drug: Tenofovir Disoproxil Fumarate Tablets of Gilead']}], 'interventions': [{'name': 'Domestic Tenofovir Disoproxil Fumarate Tablets', 'type': 'DRUG', 'description': '1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead', 'armGroupLabels': ['Domestic Tenofovir Disoproxil Fumarate Tablets']}, {'name': 'Tenofovir Disoproxil Fumarate Tablets of Gilead', 'type': 'DRUG', 'description': '1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead', 'armGroupLabels': ['Tenofovir Disoproxil Fumarate Tablets of Gilead']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao hua Hao, doctor', 'role': 'CONTACT', 'email': 'xiaohualuck@sina.com', 'phone': '13466590802'}], 'facility': 'Beijing Ditan Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li qin Yu, doctor', 'role': 'CONTACT', 'email': 'jgbgs090101@126.com', 'phone': '010-66119025'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Wang, doctor', 'role': 'CONTACT', 'email': 'jgbgs090101@126.com', 'phone': '010-88325988'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei xia Wang, doctor', 'role': 'CONTACT', 'email': 'youangcp@163.com', 'phone': '010-83997322'}], 'facility': 'Beijing You An Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400039', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong chuan Chen, doctor', 'role': 'CONTACT', 'email': 'zwmcyc@163.com', 'phone': '13883405537'}], 'facility': 'First Affiliated Hospital, Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Huang, doctor', 'role': 'CONTACT', 'email': 'sankyk@163.com', 'phone': '02085253153'}], 'facility': 'Third Affiliated Hospital of Sun Yat-sen', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiu Jin, doctor', 'role': 'CONTACT', 'phone': '13526660319'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Li, doctor', 'role': 'CONTACT', 'phone': '13526506270'}], 'facility': 'First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '210003', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Pan, doctor', 'role': 'CONTACT', 'phone': '13814099474'}], 'facility': 'The Second Hospital of Nanjing', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xu Huang, doctor', 'role': 'CONTACT', 'email': 'jsphkj@163.com', 'phone': '02568136360'}], 'facility': 'First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi feng Wang, doctor', 'role': 'CONTACT', 'email': 'ruijin_gcp@126.com', 'phone': '02154661789'}], 'facility': 'Ruijin Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Dong, doctor', 'role': 'CONTACT', 'phone': '02152888041'}], 'facility': 'Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201508', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Na Li, doctor', 'role': 'CONTACT', 'email': 'lina40125@shaphc.org', 'phone': '18916082023'}], 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdou', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Liao, doctor', 'role': 'CONTACT', 'email': 'hxcrgcp@163.com', 'phone': '15828323384'}], 'facility': 'West China Hospital of Sichuan University'}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li hua Wu, doctor', 'role': 'CONTACT', 'phone': '13819195192'}], 'facility': 'First Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yan yan Yu, doctor', 'role': 'CONTACT', 'email': 'yyy@bjnu.edu', 'phone': '13901194223'}], 'overallOfficials': [{'name': 'Yan yan Yu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}, {'name': 'Hao Wang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Jun Chen, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Ditan Hospital'}, {'name': 'Xin yue Chen, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing You An Hospital, Capital Medical University'}, {'name': 'Wen hong Zhang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}, {'name': 'Qing Xie, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Shan ming Wu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Public Health Clinical Center'}, {'name': 'Hong Tang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}, {'name': 'Qing Mao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Third Military Medical University'}, {'name': 'Zhi liang Gao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third Affiliated Hospital of Sun Yat-sen'}, {'name': 'Ji fang Shen, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}, {'name': 'Jun Li, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Wei Zhao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Nanjing Medical University'}, {'name': 'Jia Shang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Henan Provincial People's Hospital"}, {'name': 'Zu jiang Yu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}