Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-03-28 @ 7:17 AM
Study NCT ID:
NCT02745704
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2016-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-12', 'studyFirstSubmitDate': '2016-04-11', 'studyFirstSubmitQcDate': '2016-04-17', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBsAg Clearance', 'timeFrame': '72 weeks', 'description': 'Percentage of Participants with HBsAg negative.'}, {'measure': 'HBsAg Seroconversion', 'timeFrame': '72 weeks', 'description': 'Percentage of Participants with HBsAg negative and anti-HBsAg positive.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic hepatitis B', 'peginterferon alfa'], 'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.', 'detailedDescription': 'In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. CHB patients who had received NAs for more than 12 months.\n2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.\n3. Hepatitis B surface antigen (HBsAg) positive and \\<1500 IU/mL.\n4. Hepatitis B virus DNA not detectable(Roche Cobas).\n\nExclusion Criteria:\n\n1. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.\n2. Patients with other factors causing liver diseases.\n3. Pregnant and lactating women.\n4. Patients with concomitant HIV infection or congenital immune deficiency diseases.\n5. Patients with diabetes, autoimmune diseases.\n6. Patients with important organ dysfunctions.\n7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)\n8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.\n9. Patients who can't come back to clinic for follow-up on schedule."}, 'identificationModule': {'nctId': 'NCT02745704', 'briefTitle': 'The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg', 'orgStudyIdInfo': {'id': '3rd-SYSU-I-Cure'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-IFN group', 'description': 'Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg \\<1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.', 'interventionNames': ['Drug: Peginterferon alfa']}, {'type': 'NO_INTERVENTION', 'label': 'NAs group', 'description': 'Patients do not need to change their NAs treatment.'}], 'interventions': [{'name': 'Peginterferon alfa', 'type': 'DRUG', 'description': 'peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week', 'armGroupLabels': ['PEG-IFN group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Zhu, Doctor', 'role': 'CONTACT', 'email': '0628zhuxiang@163.com', 'phone': '13826452564'}], 'facility': 'The third affiliated hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University', 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Nanchang University', 'class': 'OTHER'}, {'name': 'Huizhou Municipal Central Hospital', 'class': 'OTHER'}, {'name': "First People's Hospital, Shunde China", 'class': 'OTHER'}, {'name': "Shenzhen Third People's Hospital", 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Kunming Medical University', 'class': 'OTHER'}, {'name': "Yuebei People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief director of department of infectious disease', 'investigatorFullName': 'Zhiliang Gao', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}