Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT00460850
Status:
TERMINATED
Last Update Posted:
2008-06-30
First Post:
2007-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative 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': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Low recruitment rate due to treatment regimen change', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-27', 'studyFirstSubmitDate': '2007-04-16', 'studyFirstSubmitQcDate': '2007-04-16', 'lastUpdatePostDateStruct': {'date': '2008-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normalization of ALT, and HBV-DNA <10,000 copies/mL', 'timeFrame': 'Week 96'}], 'secondaryOutcomes': [{'measure': 'Normalization of ALT, and HBV-DNA <10,000 copies/mL', 'timeFrame': 'Weeks 48 and 72'}, {'measure': 'HBsAg loss and anti-HBs seroconversion', 'timeFrame': 'Weeks 48, 72 and 96'}, {'measure': 'AEs and lab parameters', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-65 years of age;\n* HBeAg negative chronic hepatitis B;\n* treated with lamivudine for \\>=6 months;\n* demonstrated lamivudine resistance;\n* compensated liver disease.\n\nExclusion Criteria:\n\n* severe hepatic dysfunction;\n* previous treatment with antivirals other than lamivudine;\n* immunosuppressant treatment in past 6 months;\n* co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;\n* medical condition associated with chronic liver disease.'}, 'identificationModule': {'nctId': 'NCT00460850', 'briefTitle': 'A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'ML20135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: peginterferon alfa-2a (40KD) [PEGASYS]']}], 'interventions': [{'name': 'peginterferon alfa-2a (40KD) [PEGASYS]', 'type': 'DRUG', 'description': '180 micrograms sc weekly for 48 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06620', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '07058', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'zip': '34390', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35360', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Trials, Study Director', 'oldOrganization': 'Hoffmann-La Roche'}}}}