Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 2:35 AM
Study NCT ID:
NCT01667432
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2012-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population: All participants who received at least 1 dose of peginterferon alfa-2a and had at least 1 post-baseline safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Peginterferon Alfa-2a', 'description': 'Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.', 'otherNumAtRisk': 139, 'otherNumAffected': 78, 'seriousNumAtRisk': 139, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Leucopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2a', 'description': 'Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000', 'lowerLimit': '30.70', 'upperLimit': '47.48'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of the study (Week 36)', 'description': 'Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml', 'timeFrame': 'approximately 3 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2a', 'description': 'Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.'}], 'classes': [{'title': 'HBeAg positive (n = 4)', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '10.92', 'upperLimit': '69.21'}]}]}, {'title': 'HBeAg negative (n = 33)', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '19.8', 'upperLimit': '35.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of treatment (Week 24)', 'description': 'Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative', 'timeFrame': 'approximately 3 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients', 'timeFrame': 'approximately 3 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients', 'timeFrame': 'approximately 3 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio', 'timeFrame': 'approximately 3 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive', 'timeFrame': 'approximately 3 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Safety: Incidence of Adverse Events', 'timeFrame': 'approximately 3 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peginterferon Alfa-2a', 'description': 'Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Premature Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Moved to Another Center', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Refused Treatment/Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Principal Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Missing Information', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Peginterferon Alfa-2a', 'description': 'Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.10', 'spread': '10.45', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2012-08-15', 'resultsFirstSubmitDate': '2015-10-01', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-03', 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study', 'timeFrame': 'At the end of the study (Week 36)', 'description': 'Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).'}, {'measure': 'Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml', 'timeFrame': 'approximately 3 years'}, {'measure': 'In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive', 'timeFrame': 'approximately 3 years'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment', 'timeFrame': 'At the end of treatment (Week 24)', 'description': 'Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.'}, {'measure': 'HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative', 'timeFrame': 'approximately 3 years'}, {'measure': 'Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients', 'timeFrame': 'approximately 3 years'}, {'measure': 'Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients', 'timeFrame': 'approximately 3 years'}, {'measure': 'Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio', 'timeFrame': 'approximately 3 years'}, {'measure': 'Safety: Incidence of Adverse Events', 'timeFrame': 'approximately 3 years'}]}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis B on treatment with PEGASYS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age.\n* Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.\n* Elevated alanine aminotransferase (ALT) \\> upper limit of normal (ULN) but ≤ 10 x ULN according to local label.\n\nExclusion Criteria:\n\n* Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.\n* Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).\n* Concomitant treatment with telbivudine.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT01667432', 'briefTitle': 'An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)', 'orgStudyIdInfo': {'id': 'ML25626'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peginterferon alfa-2a', 'description': 'Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.', 'interventionNames': ['Biological: Peginterferon alfa-2a']}], 'interventions': [{'name': 'Peginterferon alfa-2a', 'type': 'BIOLOGICAL', 'otherNames': ['PEGASYS®', 'RO0258310'], 'description': 'Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.', 'armGroupLabels': ['Peginterferon alfa-2a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Mhat - Pleven; Clinic of Gastroenterology', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Umhat St. Georgi; Clinical of Gastroenterology', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT Alexandrovska EAD; Gastroenterology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Mhat Queenjoanna; Clinic of Gastroenterology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Military Medical Academy; Gastroenterology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Mhat St. Ivan Rilski; Clinic of Gastroenterology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6000', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Mhat St. Zagora; Clinical of Gastroenterology', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Mhat Sveta Marina; Clinic of Gastroenterology', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}