Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-29 @ 7:08 AM
Study NCT ID:
NCT01645969
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-07-18', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Correlation of duration of response with on-treatment response (HBeAg/HBV DNA/HBsAg/ALT)', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective, observational study will evaluate the one-year outcomes in HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a) in Arm A of study ML22265. Data will be collected from each patient for up to one year post-therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received treatment and completed follow-up in study arm "A" of study ML22265', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were randomized to study Arm A of ML22265 and were treated and completed follow-up in the study, regardless of treatment response at any time point\n\nExclusion Criteria:\n\n* Patients unwilling to provide informed consent or abide by the requirements of the study'}, 'identificationModule': {'nctId': 'NCT01645969', 'briefTitle': 'A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Follow-up Study to Evaluate the One-year Post Treatment Effects of Peginterferon Alfa-2a (PEGASYS) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study ML 22265', 'orgStudyIdInfo': {'id': 'ML25647'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'country': 'China', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '350005', 'city': 'Fuzhou', 'country': 'China', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510515', 'city': 'Guangzhou', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430030', 'city': 'Wuhan', 'country': 'China', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '710038', 'city': "Xi'an", 'country': 'China', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}