Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-17 @ 6:11 PM
Study NCT ID:
NCT01088659
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2010-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019701', 'term': 'Hepatitis D, Chronic'}], 'ancestors': [{'id': 'D003699', 'term': 'Hepatitis D'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'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'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients becoming HDV-RNA negative', 'timeFrame': 'week 96'}], 'secondaryOutcomes': [{'measure': 'HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology', 'timeFrame': 'weeks 48, 96 and after 24 weeks of follow-up'}, {'measure': 'Safety and tolerability: adverse events, laboratory parameters, vital signs', 'timeFrame': 'throughout 96 weeks of treatment'}]}, 'conditionsModule': {'conditions': ['Hepatitis D, Chronic']}, 'referencesModule': {'references': [{'pmid': '30833068', 'type': 'DERIVED', 'citation': 'Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is \\<50.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>/=18 years of age\n* chronic hepatitis D\n* positive for HBsAg \\>/=6 months, for anti-HDV \\>/=3 months and for HDV-RNA at screening\n* negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study\n\nExclusion Criteria:\n\n* antiviral therapy for chronic hepatitis D within the previous 6 months\n* previous therapy with pegylated interferon alfa\n* treatment with conventional interferon alfa for \\>12 months\n* hepatitis A or C, or HIV infection\n* decompensated liver disease (Childs B-C)\n* history or evidence of medical condition associated with chronic liver disease'}, 'identificationModule': {'nctId': 'NCT01088659', 'briefTitle': 'A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis', 'orgStudyIdInfo': {'id': 'ML22364'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]', 'Drug: tenofovir']}], 'interventions': [{'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180mcg sc weekly, 96 weeks', 'armGroupLabels': ['1', '2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'orally daily, 96 weeks', 'armGroupLabels': ['1']}, {'name': 'tenofovir', 'type': 'DRUG', 'description': '245mg po daily, 96 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06620', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Medical Facility; Hepatology Department', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '16059', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'zip': '10000', 'city': 'Diyarbakır', 'country': 'Turkey (Türkiye)', 'facility': 'Dicle Uni Medical Faculty; Gastroenterology', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}, {'zip': '34390', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege Uni Medical Faculty Izmir; Gastroenterology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35340', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University Medical Faculty; Infection', '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': {'type': 'SPONSOR'}}}}