Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-03-01 @ 4:45 PM
Study NCT ID:
NCT01705704
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Biomarker Study of Stored Samples Obtained From Patients 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2012-10-10', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine', 'timeFrame': 'Samples up to 72 weeks of treatment'}, {'measure': 'Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine', 'timeFrame': 'Samples up to 72 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B', 'timeFrame': 'Samples up to 72 weeks of treatment'}, {'measure': 'Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine', 'timeFrame': 'Samples up to 72 weeks of treatment'}]}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'referencesModule': {'references': [{'pmid': '29741634', 'type': 'DERIVED', 'citation': 'van Bommel F, van Bommel A, Krauel A, Wat C, Pavlovic V, Yang L, Deichsel D, Berg T, Bohm S. Serum HBV RNA as a Predictor of Peginterferon Alfa-2a Response in Patients With HBeAg-Positive Chronic Hepatitis B. J Infect Dis. 2018 Aug 24;218(7):1066-1074. doi: 10.1093/infdis/jiy270.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stored serum samples obtained from patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with HBe-antigen positive or negative chronic hepatitis B, and no other chronic viral infections who completed therapy for Hepatitis B with Pegasys ± lamivudine\n* Inclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432\n* Samples from patients treated with either Pegasys or Pegays + lamivudine are included in this analytical study\n* Samples will only be analyzed for patients where Investigational Review Board approval has been granted\n\nExclusion Criteria:\n\n* Exclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432'}, 'identificationModule': {'nctId': 'NCT01705704', 'briefTitle': 'A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Exploratory Evaluation of Interleukin 28B (IL28B) Genotype, Single Nucleotide Polymorphisms (SNP) of rs12356193, Protein and RNA Biomarkers in Serum Samples (Stored, Already Obtained From Completed Studies) From Subjects With HBe-antigen Positive or Negative Chronic Hepatitis B, Who Have Completed Therapy for Hepatitis B With Pegasys ± Lamivudine.', 'orgStudyIdInfo': {'id': 'BV28333'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '852', 'city': 'Hong Kong', 'country': 'Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '70124', 'city': 'Bari', 'state': 'Apulia', 'country': 'Italy', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '25123', 'city': 'Brescia', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '09042', 'city': 'Cagliari', 'state': 'Sardinia', 'country': 'Italy', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '56124', 'city': 'Pisa', 'state': 'Tuscany', 'country': 'Italy', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '100', 'city': 'Auckland', 'country': 'New Zealand', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Hamilton', 'country': 'New Zealand', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '190103', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443011', 'city': 'Samara', 'country': 'Russia', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '355017', 'city': 'Stavropol', 'country': 'Russia', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '228510', 'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50202', 'city': 'Chiang Mai', 'country': 'Thailand', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '90112', 'city': 'Songkhla', 'country': 'Thailand', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}