NCT06550128已完成2 期
Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in HBeAg-negative CHB Subjects Under Stable Nucleos(t)Ide Analogue (NA) Treatment
Ausper Biopharma Co., Ltd.11 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年7月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 11
- 主要终点
- Proportion of participants achieving HBsAg < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment.
研究概览
简要总结
AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.
详细描述
The study is to evaluate the efficacy and safety of AHB-137 in HBeAg-negative CHB subjects. The total duration of the study, including screening phase, treatment phase and follow-up phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study and discontinue their NA therapy according to the protocol;
- •At least 18 years old at the time of signing of the informed consent;
- •Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive) ;
- •Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening;
- •Participants whose serum HBsAg positive for at least 6 months prior to screening;
- •Participants who have stable on NA therapy at least 6 months prior to screening;
- •Participants with HBsAg concentration >100 IU/mL and≤3000 IU/mL, HBV DNA<100 IU/mL;
- •Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN);
- •For women of childbearing potential, she should be non-pregnant or non-lactating during screening, and participants (and partners) are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing.
排除标准
- •Clinical significant abnormalities except Chronic HBV infection, such as acute coronary syndrome within 6 months before screening, evidence of major surgery, major or unstable heart disease, bleeding tendency or significant coagulation disorder within 3 months before screening;
- •Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Drug-induced liver injury, etc.;
- •Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;
- •Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
- •Liver stiffness measurement (LSM) > 9.0 kPa when screening;
- •Diagnosed or suspected hepatocellular carcinoma;
- •The laboratory examination results are obviously abnormal;
- •History of vasculitis or signs and symptoms of potential vasculitis;
- •History of extrahepatic disease that may be related to HBV immune status;
- •Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study.
- •Administration of any Interferon within 6 months prior to screening;
- •History of malignant tumor within the past 5 years;
- •Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
- •Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
- •Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
- •Concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days;
- •Any oligonucleotide or siRNA treatments within 12 months prior to first dosing;
- •Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: AHB-137 and Placebo (Drug)
AHB-137 (24 weeks)
Experimental
干预措施: AHB-137 (24 weeks) (Drug)
AHB-137 (16 weeks)
Experimental
干预措施: AHB-137 (16 weeks) (Drug)
结局指标
主要结局
Proportion of participants achieving HBsAg < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment.
时间窗: Up to 24 weeks
次要结局
- Safety: number of participants with adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results, including laboratory examination, electrocardiogram (ECG) examination, physical examination and vital signs(Up to 72 weeks)
- Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)(Up to 72 weeks)
- Changes of cytokine levels compared with baseline(Up to 72 weeks)
- The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma(Up to 72 weeks)
- The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137(Up to 72 weeks)
- Plasma concentrations of AHB-137(Up to 72 weeks)
- Proportion of participants maintaining sustained response.(Up to 72 weeks)
- Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline(Up to 72 weeks)
- Percentage of participants with different levels of HBsAg reduction compared with baseline(Up to 72 weeks)
- Serum levels of HBV DNA, HBsAg, highly sensitive HBsAg, HBcrAg, HBV RNA, HBsAb, HBeAb and HBsAg-HBsAb.(Up to 72 weeks)
- The time from the discontinuation of NA treatment to virological relapse(Up to 72 weeks)
- The time from the discontinuation of NA treatment to clinical relapse(Up to 72 weeks)
- Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance of AHB-137(Up to 24 weeks)
- Plasma concentrations of AHB-137(Up to 72 weeks)
- Proportion of participants maintaining sustained response.(Up to 72 weeks)
- Proportion of participants achieving HBsAg lower than LOD and HBV DNA lower than LLOQ , regardless of whether HBsAg seroconversion is observed(At 8 weeks)
- Proportion of participants meeting NA treatment discontinuation criteria.(Up to 48 weeks)
- Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline(Up to 72 weeks)
- Percentage of participants with different levels of HBsAg reduction compared with baseline(Up to 72 weeks)
- Serum levels of HBV DNA, HBsAg, highly sensitive HBsAg, HBcrAg, HBV RNA, HBsAb, HBeAb and HBsAg-HBsAb.(Up to 72 weeks)
- The time from the discontinuation of NA treatment to virological relapse(Up to 72 weeks)
- The time from the discontinuation of NA treatment to clinical relapse(Up to 72 weeks)
- Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance of AHB-137(Up to 24 weeks)
- Safety: number of participants with adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results, including laboratory examination, electrocardiogram (ECG) examination, physical examination and vital signs(Up to 72 weeks)
- Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)(Up to 72 weeks)
- Changes of cytokine levels compared with baseline(Up to 72 weeks)
- The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma(Up to 72 weeks)
- The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137(Up to 72 weeks)
研究者
研究点 (11)
Loading locations...
相似试验
尚未招募
2 期
A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid TumorsRecurrent Platinum-resistant Epithelial Ovarian CancerTriple Negative Breast Cancer (TNBC)Cervical CancersHepatocellular Carcinoma (HCC)Non-Squamous Non-Small Cell Lung CancerColorectal CancerSmall Cell Lung CancerNCT06724263Tasly Biopharmaceuticals Co., Ltd.120
终止
3 期
A Study of the Efficacy and Safety of ABH001 in the Treatment of Patients With Epidermolysis Bullosa Who Have Wounds That Are Not HealingEpidermolysis BullosaNCT01749306Shire Regenerative Medicine, Inc.1
Unknown
2 期
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT00174525Pharmacology Research Institute
已完成
2 期
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)GVHD, ChronicNCT04930562BioNova Pharmaceuticals (Shanghai) LTD.30
Unknown
3 期
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric CancerStomach CancerNCT04486651Taizhou Hanzhong biomedical co. LTD560