Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-21 @ 4:44 PM
Study NCT ID:
NCT01380951
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-23', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum HBV DNA', 'timeFrame': '48 weeks', 'description': 'serum HBV DNA negativity and decline from baseline at week 48'}], 'secondaryOutcomes': [{'measure': 'Serum HBeAg', 'timeFrame': '48 weeks', 'description': 'rate of HBeAg seroconversion and HBeAg loss'}, {'measure': 'Child-pugh score', 'timeFrame': '48 weeks', 'description': 'the average decline of Child-pugh score at week 48 from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver cirrhosis', 'chronic hepatitis B', 'antiviral therapy', 'telbivudine'], 'conditions': ['Liver Cirrhosis', 'Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.', 'detailedDescription': 'Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver cirrhosis with CHB\n* without history of antiviral therapy or discontinued antiviral therapy for more than 6 months\n* for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative\n* for patients with uncompensated liver cirrhosis:HBV DNA positive\n\nExclusion Criteria:\n\n* coinfection with HCV,HDV and HIV\n* AFP≥100mg/L or HCC diagnosed by iconography\n* with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT01380951', 'briefTitle': 'Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)', 'organization': {'class': 'OTHER', 'fullName': "The Fifth People's Hospital of Suzhou"}, 'officialTitle': 'Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'szwy20110610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'telbivudine', 'interventionNames': ['Drug: telbivudine']}], 'interventions': [{'name': 'telbivudine', 'type': 'DRUG', 'otherNames': ['Sebivo'], 'description': 'telbivudine 600mg/d 96 weeks', 'armGroupLabels': ['telbivudine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Honghao Zhang, B.A.', 'role': 'CONTACT', 'email': 'zhanghonghao@medmail.com.cn'}, {'name': 'Chuanwu Zhu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "the Fifth People's Hospital of Suzhou", 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'overallOfficials': [{'name': 'Chuanwu Zhu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Fifth People's Hospital of Suzhou"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The Fifth People's Hospital of Suzhou", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Chuanwu Zhu', 'oldOrganization': "the Fifth People's Hospital of Suzhou"}}}}