Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT00962533
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2009-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFicacy Optimization Research of Telbivudine Therapy
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': 'D000077712', 'term': 'Telbivudine'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 606}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-29', 'studyFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2009-08-19', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II', 'timeFrame': 'Week 104'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52', 'timeFrame': 'week 52'}, {'measure': 'Serum HBV DNA reduction from baseline at week 104', 'timeFrame': 'week 104'}, {'measure': 'Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline', 'timeFrame': 'week 104'}, {'measure': 'Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline', 'timeFrame': 'week 104'}, {'measure': 'Serum HBV DNA reduction from baseline at week 52', 'timeFrame': 'week 52'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Hepatitis B'], 'conditions': ['Hepatitis B, Chronic']}, 'referencesModule': {'references': [{'pmid': '17632041', 'type': 'BACKGROUND', 'citation': 'Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol. 2007 Aug;5(8):890-7. doi: 10.1016/j.cgh.2007.05.004. Epub 2007 Jul 13.'}, {'pmid': '32189364', 'type': 'DERIVED', 'citation': 'Huang Q, Zhou B, Cai D, Zong Y, Wu Y, Liu S, Mercier A, Guo H, Hou J, Colonno R, Sun J. Rapid Turnover of Hepatitis B Virus Covalently Closed Circular DNA Indicated by Monitoring Emergence and Reversion of Signature-Mutation in Treated Chronic Hepatitis B Patients. Hepatology. 2021 Jan;73(1):41-52. doi: 10.1002/hep.31240. Epub 2020 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, from 18 (inclusive) to 65 (inclusive) years of age\n* HBsAg and HBeAg positive for over six months\n* Patient is willing and able to comply with the study drug regimen and all other study requirements\n* Patients must give written informed consent before any assessment is performed\n\nExclusion Criteria:\n\n* Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit\n* Patient has a history of or clinical signs/symptoms of hepatic decompensation\n* Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00962533', 'acronym': 'EFFORT', 'briefTitle': 'EFFicacy Optimization Research of Telbivudine Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)', 'orgStudyIdInfo': {'id': 'MOH-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ROADMAP Group (Group I)', 'description': 'Patients were to take telbivudine 600 mg orally daily from Baseline.At Week 24, patients in Group I were split into Group I-A or Group I-B based on their virologic load:\n\n* Group I-A: This group of patients was those with HBV DNA ≥300 copies/mL at Week 24 and adefovir was to be added at Week 28;\n* Group I-B: This group of patients was those with HBV DNA \\<300 copies/mL at Week 24. Telbivudine monotherapy was to be continued until there was a viral breakthrough (confirmed by two examinations with at least 1 month interval with compliance factor excluded) and then adefovir was to be added;\n\nThe total treatment duration was 104 weeks.', 'interventionNames': ['Drug: telbivudine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOC (Standard of Care) Group (Group II)', 'description': 'patients were to take telbivudine 600 mg monotherapy from Baseline until Week 104. If viral breakthrough (defined as HBV DNA 1 log10 above nadir) was confirmed (by two examinations with at least a 1 month interval with compliance factor excluded), adefovir 10 mg daily was to be added.', 'interventionNames': ['Drug: telbivudine']}], 'interventions': [{'name': 'telbivudine', 'type': 'DRUG', 'otherNames': ['Sebivo®'], 'description': 'telbivudine, 600mg, oral, daily', 'armGroupLabels': ['ROADMAP Group (Group I)']}, {'name': 'telbivudine', 'type': 'DRUG', 'otherNames': ['Sebivo®'], 'description': 'telbivudine, 600mg, oral, daily', 'armGroupLabels': ['SOC (Standard of Care) Group (Group II)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': '302 Military Hospital of China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Ditan Hospita', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital Attached to the Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'BeiJing YouAn Hospital ,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of infectious disease, First Hospital of Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "People'S Hospital Under Beijnig University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The Second Affiliated of ChongQing University of Medical Science', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of infectious disease, Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "No. 8 People's Hospital In GuangZhou", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Third Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', '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', 'country': 'China', 'facility': 'Xiangya Hospital Central-South Univrsity', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'No.81 Hospital of PLA', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'First Hospital .Jilin Unniversity', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'ShengJing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'JiNan Infectious Diseases Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changhai Hospital affiliated to Second Military Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital，Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'No.85 Hospital of PLA', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'XiAn', 'state': 'Shanxi', 'country': 'China', 'facility': 'Tangdu Hospital'}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital.SiChuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of College of Medicine ，Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "The Sixth People's Hospital of Hangzhou", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], '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': 'Major Science and Technology Special Project of China Eleventh Five-year', 'class': 'OTHER'}, {'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}