NCT07137910招募中2 期
An Open-Label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Low-HBsAg Chronic Hepatitis B
Ausper Biopharma Co., Ltd.13 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月4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
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- 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.
研究概览
简要总结
This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the study and sign the informed consent form;
- •18-65 years of age (including boundary values) ;
- •Body mass index met the requirements;
- •Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
- •Meet the relevant requirements for prior medications;
- •HBsAg and HBV DNA and liver function indicators meet the requirements;
- •Effective contraception as required;
排除标准
- •Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
- •Associated liver disease;
- •Any serious infection other than CHB infection requires intravenous anti-infective therapy;
- •HCV RNA positive, HIV antibody positive, syphilis positive;
- •Abnormal laboratory results;
- •Diseases associated with vascular inflammatory conditions;
- •QT interval corrected heart rate (Fridericia method) abnormal;
- •History of malignancy or ongoing assessment of possible malignancy;
- •History of allergies, or allergic constitution;
- •Participants with recent major trauma or major surgery, or planning surgery;
- •Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- •Prior/current use of prohibited medications;
- •Inappropriate for participation in this trial as judged by the investigator.
研究组 & 干预措施
Part A: AHB-137 With NA Therapy
Experimental
干预措施: AHB-137 (Drug)
Part A: AHB-137 With NA Therapy
Experimental
干预措施: NA therapy (Drug)
Part B: AHB-137 Without NA Therapy
Experimental
干预措施: AHB-137 (Drug)
Part B: AHB-137 with NA Therapy
Experimental
干预措施: AHB-137 (Drug)
Part B: AHB-137 with NA Therapy
Experimental
干预措施: NA therapy (Drug)
结局指标
主要结局
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.
时间窗: At the 24th week after all treatment for CHB was discontinued
次要结局
- Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.(Up to 60 weeks)
- Relapse rate and time after discontinuation of NAs therapy.(Up to 60 weeks)
- Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline.(Up to 60 weeks)
- Proportion of participants with persistent HBV DNA < LLOQ .(During the 24-week period after discontinuation of all CHB treatment)
- Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ).(Up to 60 weeks)
- Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.(Up to 60 weeks)
- Relapse rate and time after discontinuation of NAs therapy.(Up to 60 weeks)
- Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline.(Up to 60 weeks)
- Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.(Up to 60 weeks)
- Number and percentage of participants with detectable anti-drug antibodies (ADA).(Up to 60 weeks)
- Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137.(Up to 60 weeks)
- Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.(Up to 60 weeks)
- Plasma concentrations of AHB-137.(Up to 60 weeks)
研究者
研究点 (13)
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