NCT07246889进行中（未招募）3 期
A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With HBeAg-negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogues
Ausper Biopharma Co., Ltd.28 个研究点 分布在 1 个国家目标入组 577 人开始时间: 2025年8月12日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 577
- 试验地点
- 28
- 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 study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
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 according to the protocol;
- •At least 18 years of age at the time of signing the ICF;
- •Body mass index met the requirements;
- •HBeAg negative at screening;
- •HBsAg or HBV DNA positive for at least 6 months;
- •Meet relevant requirements for NAs treatment;
- •100 IU/mL < HBsAg ≤ 3000 IU/mL, HBV DNA < 100 IU/mL and liver function indicators meet the requirements;
- •Effective contraception as required.
排除标准
- •Clinically significant abnormalities other than a history of chronic HBV infection;
- •Concomitant clinically significant other liver diseases;
- •Previous/current manifestations of hepatic decompensation;
- •Significant hepatic fibrosis or cirrhosis;
- •Presence of protocol-specified laboratory abnormalities;
- •History of malignancy or ongoing assessment of possible malignancy;
- •Those allergic to AHB-137 or its components;
- •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
AHB-137
Experimental
干预措施: AHB-137 (Drug)
AHB-137
Experimental
干预措施: NA therapy (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
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: 24 weeks after discontinuation of all CHB treatment
次要结局
- Relapse rate after discontinuation of NAs therapy.(Up to 60 weeks)
- Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).(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)
- Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ(Up to 60 weeks)
- Proportion of participants with persistent HBV DNA < LLOQ .(24 weeks after discontinuation of all CHB treatment)
- Plasma concentrations of AHB-137.(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)
- Change from baseline in EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) scores in participants with HBV infection.(Up to 60 weeks)
- Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.(Up to 60 weeks)
- Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb(Up to 60 weeks)
研究者
研究点 (28)
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