Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT07069569
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
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': 'D017325', 'term': 'Hepatitis B Vaccines'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-07-06', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.', 'timeFrame': 'up to 72 weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Relapse rate after discontinuation of NAs therapy.', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values.', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Relapse time after discontinuation of NAs therapy.', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Plasma concentrations of AHB-137.', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Serum concentrations of Peg-IFN.', 'timeFrame': 'Up to 48 weeks.'}, {'measure': 'Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Safety: Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.', 'timeFrame': 'Up to 72 weeks', 'description': 'This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life.'}, {'measure': 'Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.', 'timeFrame': 'Up to 72 weeks', 'description': 'Examination including laboratory examination, electrocardiogram (ECG) examination.'}, {'measure': 'Safety: Monitoring the score changes of Columbia Suicide Severity Scale (CSSRS) .', 'timeFrame': 'Up to 72 weeks.', 'description': 'The CSSRS is a categorical, interviewer-rated instrument that screens for suicidal ideation (five items, 0-1 each) and suicidal behavior (six items, 0-1 each); the highest positive item defines the risk level rather than a total score. For ideation items 3-5 an additional 0-5 intensity rating can be recorded. Across all items the minimum value is 0 (absent) and the maximum is 1 (present); a score of 1 on any item indicates a worse outcome and triggers escalating clinical safeguards, with any behavior item being tantamount to a suicidal event.'}, {'measure': 'Safety: Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.', 'timeFrame': 'Up to 72 weeks', 'description': "The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state."}, {'measure': 'Safety: Monitoring the score changes of Self-Rating Depression Scale (SDS).', 'timeFrame': 'Up to 72 weeks.', 'description': 'The SDS is a 20-item, 4-point Likert self-report scale that yields a raw sum of 20-80 points, conventionally converted to a standard score of 25-100 by multiplying the raw total by 1.25. Higher standard scores denote worse outcomes: \\<50 normal, 50-59 mild, 60-69 moderate, and ≥70 severe depression, with ≥70 warranting specialist evaluation and suicide-risk assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B, Chronic'], 'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;\n* Aged between 18 and 65 years at the time of signing the ICF;\n* Body mass index (BMI) within the range of 18-30 kg/ m2;\n* HBeAg negative at screening;\n* HBsAg or HBV DNA positive for at least 6 months;\n* Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;\n* Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);\n* Effective contraception as required.\n\nExclusion Criteria:\n\n* Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;\n* Clinically significant abnormalities other than a history of chronic HBV infection;\n* Concomitant clinically significant other liver diseases;\n* Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;\n* HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;\n* Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \\> 9.0 kPa;\n* Previous/current manifestations of hepatic decompensation;\n* Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening;\n* Obviously abnormal laboratory test results;\n* History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous/current other diseases that may be related to vasculitic conditions;\n* QT interval corrected for heart rate (Fridericia method) abnormal;\n* History of extrahepatic disease possibly related to HBV immune status;\n* Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy;\n* Serious mental illness or history of serious mental illness prior to screening;\n* Suspected history of allergy to any component of the study drug, or allergic constitution;\n* Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;\n* Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;\n* Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial;\n* Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs;\n* Thyroid dysfunction;\n* Patients with uncontrolled epilepsy and other progressive neurological disorders;\n* Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;\n* Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.'}, 'identificationModule': {'nctId': 'NCT07069569', 'briefTitle': 'A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ausper Biopharma Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)', 'orgStudyIdInfo': {'id': 'AB-10-8007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AHB-137 (16 weeks) and Peg-IFN', 'interventionNames': ['Drug: AHB-137', 'Drug: Peg-IFN']}, {'type': 'EXPERIMENTAL', 'label': 'AHB-137 (24 weeks) and Peg-IFN', 'interventionNames': ['Drug: AHB-137', 'Drug: Peg-IFN']}, {'type': 'EXPERIMENTAL', 'label': 'AHB-137 and Hepatitis B vaccine', 'interventionNames': ['Drug: AHB-137', 'Drug: Hepatitis B Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'AHB-137', 'interventionNames': ['Drug: AHB-137']}], 'interventions': [{'name': 'AHB-137', 'type': 'DRUG', 'description': 'AHB-137 will be injected.', 'armGroupLabels': ['AHB-137', 'AHB-137 (16 weeks) and Peg-IFN', 'AHB-137 (24 weeks) and Peg-IFN', 'AHB-137 and Hepatitis B vaccine']}, {'name': 'Peg-IFN', 'type': 'DRUG', 'description': 'Peg-IFN will be administered .', 'armGroupLabels': ['AHB-137 (16 weeks) and Peg-IFN', 'AHB-137 (24 weeks) and Peg-IFN']}, {'name': 'Hepatitis B Vaccine', 'type': 'DRUG', 'description': 'Hepatitis B vaccine will be administered.', 'armGroupLabels': ['AHB-137 and Hepatitis B vaccine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ausper Biopharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}