Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT05760703
Status:
TERMINATED
Last Update Posted:
2023-12-19
First Post:
2023-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects of adverse events', 'timeFrame': 'Baseline to Day 180'}, {'measure': 'Number of subjects With Significant Abnormal Physical Examination', 'timeFrame': 'Baseline to Day 180'}, {'measure': 'Number of subjects of Significant Abnormal Vital Signs Findings', 'timeFrame': 'Baseline to Day 180'}, {'measure': 'Number of Participants With Significant Abnormal Laboratory Values', 'timeFrame': 'Baseline to Day 180'}, {'measure': 'Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings', 'timeFrame': 'Baseline to Day 180'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis b']}, 'descriptionModule': {'briefSummary': 'This trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of STSG-0002 injection in patients with chronic hepatitis B treated with oral antiviral therapy(Long-term follow-up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic HBV；\n* Receiving anti-HB viral therapy；\n* 10 IU/ml≤HBsAg≤3000 IU/ml.\n\nExclusion Criteria:\n\n* Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV;\n* Liver cirrhosis;\n* Hepatocellular carcinoma;\n* Autoimmune liver disease;\n* Clinical hepatic decompensation;\n* Fibroscan\\>12 kPa;\n* a. hemoglobin\\<110g/L（female）\\<120 g/L（male），platelet\\<ULN，white blood cell\\<2.5×109/L；b. bilirubin\\>1.5 ×ULN，ALT\\>2 × ULN，serum albumin\\<35 g/L；c. INR\\>1.5；d. serum creatinine \\>1.5×ULN.'}, 'identificationModule': {'nctId': 'NCT05760703', 'briefTitle': 'Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Staidson (Beijing) Biopharmaceuticals Co., Ltd'}, 'officialTitle': 'Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy(Long-term Follow-up)', 'orgStudyIdInfo': {'id': 'STS-STSG0002-002-LTFU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lowest dose treatment group', 'description': 'Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements', 'interventionNames': ['Drug: STSG-0002 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'low dose treatment group', 'description': 'Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements', 'interventionNames': ['Drug: STSG-0002 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Intermediate dose treatment group', 'description': 'Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements', 'interventionNames': ['Drug: STSG-0002 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'A single high dose of treatment group', 'description': 'Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements', 'interventionNames': ['Drug: STSG-0002 Injection']}], 'interventions': [{'name': 'STSG-0002 Injection', 'type': 'DRUG', 'description': 'Intravenous infusion', 'armGroupLabels': ['A single high dose of treatment group', 'Intermediate dose treatment group', 'low dose treatment group', 'lowest dose treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Youan Hospital,Capital Medical', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '401437', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Chongqing Medical', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Guiqiang Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Staidson (Beijing) Biopharmaceuticals Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Beijing Sanuo Jiayi Biotechnology Co. LTD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}