Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-30 @ 7:18 AM
Study NCT ID:
NCT00035633
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2002-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
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': 'C413685', 'term': 'entecavir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'statusVerifiedDate': '2010-01', 'dispFirstSubmitDate': '2010-01-28', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2002-05-04', 'dispFirstSubmitQcDate': '2010-01-28', 'studyFirstSubmitQcDate': '2002-05-05', 'dispFirstPostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '16525137', 'type': 'RESULT', 'citation': 'Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, Lok AS, Han KH, Goodman Z, Zhu J, Cross A, DeHertogh D, Wilber R, Colonno R, Apelian D; BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1001-10. doi: 10.1056/NEJMoa051285.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Male and female subjects =/\\> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection;\n* Documentation of positive Hepatitis B e antigen (HBeAg) status.;\n* The absence of coinfection with immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);\n* The absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;\n* Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)'}, 'identificationModule': {'nctId': 'NCT00035633', 'briefTitle': 'A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'orgStudyIdInfo': {'id': 'AI463-022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Entecavir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Local Investigator', 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-80.84313}}, {'zip': '44125', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02908', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Investigator Meeting', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Local Investigator', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}