Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT07183293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C015378', 'term': 'nas'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in liver histological score from baseline', 'timeFrame': '24 weeks after the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Incidence of hepatocellular carcinoma (HCC)', 'timeFrame': 'Week 48'}, {'measure': 'Incidence of hepatic decompensation events', 'timeFrame': 'Week 48'}, {'measure': 'Change in liver stiffness measurement (LSM) from baseline', 'timeFrame': 'Week 48,24 weeks after the end of treatment', 'description': 'Evaluation is performed using liver imaging data such as liver MRI and histopathological data.'}, {'measure': 'Change in AST-to-Platelet Ratio Index (APRI) from baseline', 'timeFrame': 'Week 48,24 weeks after the end of treatment'}, {'measure': 'Change in Fibrosis-4 Index (FIB-4) from baseline', 'timeFrame': 'Week 48,24 weeks after the end of treatment'}, {'measure': 'HBsAg loss rate', 'timeFrame': 'Week 48,24 weeks after the end of treatment'}, {'measure': 'Seroconversion rate', 'timeFrame': 'Week 48,24 weeks after the end of treatment'}, {'measure': 'HBeAg loss rate', 'timeFrame': 'Week 48,24 weeks after the end of treatment'}, {'measure': 'HBV DNA undetectability rate', 'timeFrame': 'Week 48,24 weeks after the end of treatment'}, {'measure': 'HBV RNA undetectability rate', 'timeFrame': 'Week 48,24 weeks after the end of treatment'}, {'measure': 'HBV RNA decline rate', 'timeFrame': 'Week 48,24 weeks after the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peginterferon α-2b'], 'conditions': ['HBV-related Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV/TAF/TMF/TDF) or NAs (ETV/TAF/TMF/TDF) monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of compensated HBV-related liver cirrhosis (Child-Pugh class A or B);\n2. The subject is able to understand and comply with the content, requirements, and restrictions of the protocol, is willing and able to complete the study per protocol requirements, fully understands the potential adverse reactions, and voluntarily provides written informed consent prior to study initiation;\n3. Aged 18 to 60 years (inclusive), any gender;\n4. Female subjects of childbearing potential must have a negative pregnancy test at screening;\n5. Subjects (including their partners) must voluntarily use effective non-drug contraception from prior to dosing until six months after discontinuation of the study drug and have no plan to donate sperm or ova; or subjects (including their partners) are of non-childbearing potential (surgically sterilized or postmenopausal).\n\nExclusion Criteria:\n\n1. Decompensated liver cirrhosis, hepatic failure, or hepatocellular carcinoma; presence of other liver diseases such as fatty liver disease, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or Wilson's disease;\n2. History of clinically significant diseases of the cardiovascular, hematological and lymphatic, respiratory, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy), ophthalmic diseases, or thyroid-related disorders;\n3. Pregnancy, lactation, or intention to become pregnant during the study period;\n4. Known or suspected allergy to the investigational product(s) or any of its excipients;\n5. Participation in any other interventional clinical trial within 3 months prior to screening or planning to participate in another clinical trial during the study;\n6. Any other condition considered by the investigator to be inappropriate for participation in the study."}, 'identificationModule': {'nctId': 'NCT07183293', 'briefTitle': 'A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen Humanity Hospital'}, 'officialTitle': 'A Multicenter, Randomized, Prospective Study on the Efficacy and Safety of Peginterferon Alfa-2b Combined With Nucleos(t)Ide Analogues in Patients With Compensated HBV-Related Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'HAXM20250731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Drug: Peginterferon alfa-2b combined with NAs']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Drug: NAs']}], 'interventions': [{'name': 'Peginterferon alfa-2b combined with NAs', 'type': 'DRUG', 'description': "Subcutaneous injection therapy,Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.", 'armGroupLabels': ['Group 1']}, {'name': 'NAs', 'type': 'DRUG', 'description': "Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.", 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xiamen', 'country': 'China', 'contacts': [{'name': 'Hong Cai', 'role': 'CONTACT'}], 'facility': 'Xiamen Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Xiamen', 'country': 'China', 'contacts': [{'name': 'Ligang Chen', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital Affiliated to Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Wenqi Huang', 'role': 'CONTACT', 'email': 'huangwenqi@haxm.com', 'phone': '18965179823'}], 'overallOfficials': [{'name': 'Wenqi Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiamen Humanity Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen Humanity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Wenqi Huang', 'investigatorAffiliation': 'Xiamen Humanity Hospital'}}}}