Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-24 @ 2:11 AM
Study NCT ID:
NCT01794234
Status:
TERMINATED
Last Update Posted:
2016-11-02
First Post:
2013-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
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': 44}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2013-02-15', 'studyFirstSubmitQcDate': '2013-02-15', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)', 'timeFrame': 'approximately 2.5 years'}], 'secondaryOutcomes': [{'measure': 'HBs levels in correlation with treatment outcome', 'timeFrame': 'approximately 2.5 years'}, {'measure': 'For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)', 'timeFrame': 'approximately 2.5 years'}, {'measure': 'For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization', 'timeFrame': 'approximately 2.5 years'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 2.5 years'}]}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis B initiated on therapy with Pegasys', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Positive HBsAg for more than 6 months before assignment to treatment with Pegasys\n* Detectable HBV DNA (as measured by PCR)\n* HBeAg positive and negative patients\n* Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard\n* Elevated serum alanine aminotransferase (ALT)\n* Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation\n\nExclusion Criteria:\n\n* Contraindications to treatment with Pegasys according to the Summary of Product Characteristics\n* Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver\n* Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment\n* Planned other than Pegasys antiviral treatment during Pegasys therapy\n* Chronic liver disease other than chronic hepatitis B\n* Pregnant or breast-feeding women\n* Inadequate hematologic function\n* Autoimmunology disorders\n* Co-infection with chronic hepatitis C or HIV'}, 'identificationModule': {'nctId': 'NCT01794234', 'briefTitle': 'An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Efficacy and Safety of Peginterferon Alfa-2a (40 KD) in Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment With Nucleoside (Nucleotide) Analogues - an Observational Study in Real-life Clinical Practice', 'orgStudyIdInfo': {'id': 'ML28346'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-902', 'city': 'Bytom', 'country': 'Poland', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}, {'zip': '39-200', 'city': 'Dębica', 'country': 'Poland', 'geoPoint': {'lat': 50.05146, 'lon': 21.41141}}, {'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31-202', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '41-400', 'city': 'Mysłowice', 'country': 'Poland', 'geoPoint': {'lat': 50.20745, 'lon': 19.16668}}, {'zip': '47-400', 'city': 'Racibórz', 'country': 'Poland', 'geoPoint': {'lat': 50.09195, 'lon': 18.21928}}, {'zip': '51-149', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '37-100', 'city': 'Łańcut', 'country': 'Poland', 'geoPoint': {'lat': 50.06871, 'lon': 22.22912}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}