Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02075294
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Adefovir and Entecavir for Elderly 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': 'C106812', 'term': 'adefovir dipivoxil'}, {'id': 'C413685', 'term': 'entecavir'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-26', 'studyFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rates of serum HBVDNA undetectable and Renal dysfunction', 'timeFrame': '3years'}], 'secondaryOutcomes': [{'measure': 'the rate of normalisation of ALT', 'timeFrame': 'at week 2、4、12、24、36、48、60、72、84、96'}, {'measure': 'the rate of HBsAg negative', 'timeFrame': 'at week48、96、144'}, {'measure': 'the rate of HBeAg seroconversion', 'timeFrame': 'at week 24、48、72、96、120、144'}, {'measure': 'the rate of HBeAg negative', 'timeFrame': 'at week 24、48、72、96、120、144'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aged', 'Hepatitis B, Chronic', 'Antiviral Agents'], 'conditions': ['Hepatitis B, Chronic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.302hospital.com/Html/Index.html', 'label': 'Click here for more recruit information about this study'}]}, 'descriptionModule': {'briefSummary': 'It is estimated that 350-400 million people have chronic infection with hepatitis B virus (HBV) all over the world. In china, 93 million individuals suffer from this chronic condition. Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one of the longer average life spans, and the size of the aged population has been increasing rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the potential for development of cirrhosis or hepatocellular carcinoma in such patients is real. Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has become first choice due to the more side effect of INF and the resistant of LAM and LdT. But treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the emergence rate of side effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We retrospectively analyzed a consecutive cohort of chronic hepatitis B patients treated with ADV, 10mg, daily, or with ETV，0.5mg，daily between January 2010 and December 2013 in a single tererral referral hospital in Beijing. Data were retrieved from a prospectively maintined database.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age≥18 years\n2. HBsAg positive for more than 6 months before enrollment\n3. Serum HBVDNA \\>2×104IU/ml and serum ALT \\>80U/L or TBIL \\< 34 umol/L for chronic hepatitis B\n4. Serum ALT \\< 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B\n5. Serum HBVDNA \\>40 IU/ml for cirrhosis regardless of ALT and TBIL\n\nExclusion Criteria:\n\n1. Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined\n2. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment\n3. Renal function: creatinine \\>1.5 ULN or eGFR\\< 50ml/min/1.73m2 before therapy\n4. Combined with hepatocarcinoma before therapy\n5. suspend therapy voluntarily\n6. use other nephrotoxic drugs'}, 'identificationModule': {'nctId': 'NCT02075294', 'briefTitle': 'Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'YNKT201313'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'youth', 'description': '\\<45years\n\nAdefovir dipivoxil or Entecavir\n\nParticipants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.\n\nParticipants who received 0.5mg ETV more than 3 years will be recruited.', 'interventionNames': ['Drug: Adefovir dipivoxil or Entecavir']}, {'label': 'middle age', 'description': '≥45years and\\<65years\n\nAdefovir dipivoxil or Entecavir\n\nParticipants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.\n\nParticipants who received 0.5mg ETV more than 3 years will be recruited.', 'interventionNames': ['Drug: Adefovir dipivoxil or Entecavir']}, {'label': 'elderly', 'description': '≥65 years\n\nAdefovir dipivoxil or Entecavir\n\nParticipants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.\n\nParticipants who received 0.5mg ETV more than 3 years will be recruited.', 'interventionNames': ['Drug: Adefovir dipivoxil or Entecavir']}], 'interventions': [{'name': 'Adefovir dipivoxil or Entecavir', 'type': 'DRUG', 'otherNames': ['ADV, Hepsera,', 'ETV, Baraclude'], 'description': 'Adefovir tablet, 10mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines.\n\nEntecavir tablet, 0.5mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines', 'armGroupLabels': ['elderly', 'middle age', 'youth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': '302 military hospital of China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ying-Jie Ji, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing 302 Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ying-Jie Ji', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ying-Jie Ji', 'investigatorAffiliation': 'Beijing 302 Hospital'}}}}