Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT06357806
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'C015378', 'term': 'nas'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of HBsAg loss at 24 weeks and 48 weeks.', 'timeFrame': '48 weeks', 'description': 'Evaluate the level of HBsAg at 24 weeks and 48 weeks.'}, {'measure': 'Incidence of treatment-emergent adverse events/serious adverse events', 'timeFrame': '48 weeks', 'description': 'Evaluate the treatment-emergent adverse events/serious adverse events'}], 'secondaryOutcomes': [{'measure': 'The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks', 'timeFrame': '48 weeks', 'description': 'Evaluate the level of serum HBsAg at 24 weeks and 48 weeks.'}, {'measure': 'The rate of HBsAb positive at 24 weeks and 48 weeks.', 'timeFrame': '48 weeks', 'description': 'Evaluate the level of serum HBsAb at 24 weeks and 48 weeks.'}, {'measure': 'The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.', 'timeFrame': '48 weeks', 'description': 'Evaluate the level of serum HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.'}, {'measure': 'The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.', 'timeFrame': '48 weeks', 'description': 'Evaluate the level of serum pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.'}, {'measure': 'The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.', 'timeFrame': '48 weeks', 'description': 'Evaluate the level of serum anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.'}, {'measure': 'Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks.', 'timeFrame': '48 weeks', 'description': 'Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '40976664', 'type': 'DERIVED', 'citation': 'Wang H, Li X, Lu J, Zhang X, Dang S, Li Y, He Y, Guo Y, Wang J, Maimaitijiang W, Zheng S, Ren S, Cao H, Zhang W, Zhang X, Ma H, Wang FS, Fu J. Safety and efficacy of PD-1 antibody combined with pegylated interferon alpha for functional cure in nucleos(t)ide analogues-suppressed chronic hepatitis B patients: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e105710. doi: 10.1136/bmjopen-2025-105710.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 - 65 years old;\n2. Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);\n3. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;\n4. HBV DNA and HBeAg turn negative after NAs treatment;\n5. HBsAg ranged 200-1000 IU/ml.\n\nExclusion Criteria:\n\n1. Cirrhosis;\n2. platelet count \\< 90×10\\^9/L, WBC count \\< 3.0×10\\^9/L, neutrophil count \\< 1.3×10\\^9/L, ALT \\> ULN（40U/L）, total bilirubin \\> 2ULN;\n3. History of or suspicion of hepatocellular carcinoma\n4. Patients received interferon therapy within 12 months;\n5. Patients received immunosuppressive therapy or other therapy influenced study within 12 months;\n6. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;\n7. Alcohol or drug abuse/dependence;\n8. Investigator judges that the participants are not suitable for this study.'}, 'identificationModule': {'nctId': 'NCT06357806', 'briefTitle': 'The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'The Safety and Efficacy of PD-1 Antibody Combined With Pegylated Interferon-α Therapy to Promote the Clinical Cure in Nucleoside (Acid) Analogues-suppressed Chronic Hepatitis B Patients: A Protocol for the Prospective Pilot Study', 'orgStudyIdInfo': {'id': 'PIN-CHB-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peg-IFNα group', 'description': '180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs', 'interventionNames': ['Drug: Peg-IFNα-2b', 'Drug: NAs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PD-1 antibody group', 'description': '1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs', 'interventionNames': ['Drug: Sintilimab', 'Drug: NAs']}, {'type': 'EXPERIMENTAL', 'label': 'PD-1 antibody combined Peg-IFNα group', 'description': '1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs', 'interventionNames': ['Drug: Sintilimab', 'Drug: Peg-IFNα-2b', 'Drug: NAs']}], 'interventions': [{'name': 'Sintilimab', 'type': 'DRUG', 'description': '100mg/10ml/1bottle', 'armGroupLabels': ['PD-1 antibody combined Peg-IFNα group', 'PD-1 antibody group']}, {'name': 'Peg-IFNα-2b', 'type': 'DRUG', 'description': '180ug/0.5ml/1bottle', 'armGroupLabels': ['PD-1 antibody combined Peg-IFNα group', 'Peg-IFNα group']}, {'name': 'NAs', 'type': 'DRUG', 'otherNames': ['ETV/TDF/TAF'], 'description': 'tablets', 'armGroupLabels': ['PD-1 antibody combined Peg-IFNα group', 'PD-1 antibody group', 'Peg-IFNα group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junliang Fu, MD', 'role': 'CONTACT', 'email': 'fjunliang@163.com', 'phone': '010-66933214'}], 'facility': 'the Fifth Medical Center, Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Junliang Fu', 'role': 'CONTACT', 'email': 'fjunliang@163.com', 'phone': '86-10-66933214'}, {'name': 'Fu-Sheng Wang, MD', 'role': 'CONTACT', 'email': 'fswang302@163.com', 'phone': '86-10-66933328'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}