Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-28 @ 6:46 PM
Study NCT ID:
NCT01179594
Status:
WITHDRAWN
Last Update Posted:
2017-02-17
First Post:
2010-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Brazil', 'Germany', 'Greece', 'India', 'South Korea', 'Thailand', 'Turkey (Türkiye)']}, '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'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study was canceled for operational reasons.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-09-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2010-08-10', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)', 'timeFrame': '48 weeks after the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Correlation early HBsAg response - response end of treatment/follow-up', 'timeFrame': 'every 6 weeks up to week 48, every 12 weeks therafter'}]}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a \\[Pegasys\\], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is \\<500 patients.'}, '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 B for \\>/= 6 months\n* HBeAg negative at screening\n* adequate renal function\n\nExclusion Criteria:\n\n* antiviral therapy for chronic hepatitis B within the previous 6 months\n* hepatitis A, C, D or HIV infection\n* treatment with systemic acyclovir or famciclovir within the previous 6 months\n* decompensated liver disease (Childs B-C)\n* history or evidence of a medical condition associated with chronic liver disease'}, 'identificationModule': {'nctId': 'NCT01179594', 'briefTitle': 'A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.', 'orgStudyIdInfo': {'id': 'MV22597'}, 'secondaryIdInfos': [{'id': '2009-017602-36'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: entecavir', 'Drug: peginterferon alfa-2a [Pegasys]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'interventionNames': ['Drug: entecavir', 'Drug: peginterferon alfa-2a [Pegasys]']}], 'interventions': [{'name': 'entecavir', 'type': 'DRUG', 'description': '0.5 mg orally daily, 24 weeks (weeks 12-36)', 'armGroupLabels': ['B', 'D']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180 mcg sc weekly, 48 weeks', 'armGroupLabels': ['A', 'B']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180 mcg sc weekly, 96 weeks', 'armGroupLabels': ['C', 'D']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'orally daily, 24 weeks (weeks 12-36)', 'armGroupLabels': ['A', 'C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}