NCT06993480进行中（未招募）2 期
A Single-Center, Open-Label Phase II Clinical Study to Evaluate the Antiviral Activity and Immune Responses of AHB-137 Injection in Participants With CHB Treated With Nucleos (t) Ide Analogues
Ausper Biopharma Co., Ltd.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月15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
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion.
研究概览
简要总结
This study is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.
详细描述
The study is to evaluate the antiviral activity and immune response of AHB-137 injection in participants with CHB treated with nucleos(t)ide analogues. The study is proposed to enroll 20-30 patients, with a total study duration of approximately 56 weeks per participants, including a screening period (up to 4 weeks), a clinical study lead-in period (approximately 4 weeks), an AHB-137 treatment period (24 weeks) and a follow-up period (24 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participated in the study and signed an informed consent form;
- •Aged between 18 and 55 years at the time of signing the informed consent form;
- •Body mass index (BMI) within the range of 18-30 kg/ m2;
- •HBeAg negative or positive at screening;
- •HBsAg or HBV DNA positive for at least 6 months;
- •Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening;
- •100 IU/mL < HBsAg ≤ 3000 IU/mL and HBV DNA < 100 IU/mL at screening;
- •Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
- •Effective contraception as required.
排除标准
- •Clinically significant abnormalities other than a history of CHB infection;
- •Concomitant clinically significant other liver diseases;
- •Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening;
- •Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
- •Liver stiffness value (LSM) > 9.0 kPa at screening;
- •Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening;
- •Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis;
- •Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage;
- •History of extrahepatic disease possibly related to HBV immune status;
- •Ongoing or taking any immunosuppressive medication within 3 months prior to screening. Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose, or have a history of vaccination within 1 month prior to screening or have a live vaccination plan during the trial; Continuous use of traditional Chinese medicine for more than 2 months within 1 year prior to screening, or within 1 month prior to screening; Ongoing use of anticoagulants, bleeding tendency or coagulopathy, or conditions that, in the opinion of the investigator, increase the risk of liver biopsy;
- •Receiving or using any interferon-containing therapy within 12 months prior to screening;
- •History of malignancy within 5 years prior to screening or being evaluated for possible malignancy;
- •Suspected history of allergy to any component of the study drug, or allergic constitution (multiple drug and food allergy, and judged by the investigator to be clinically significant);
- •Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
- •Donation or blood loss ≥ 400 mL, or received blood transfusion within 12 weeks prior to screening; Or blood donation or blood loss ≥ 200 mL within 1 month prior to screening;
- •Participants who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- •Received any antisense oligonucleotides (ASO) or using any small molecule interfering ribonucleic acid (siRNA) drug within 12 months prior to screening;
- •Participants with abnormal thyroid function judged by the investigator to be ineligible for enrollment;
- •Obviously abnormal laboratory test results;
- •History of vasculitis or signs and symptoms of underlying vasculitis;
- •Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.
研究组 & 干预措施
AHB-137
Experimental
AHB-137 will be injected subcutaneously.
干预措施: AHB-137 (Drug)
结局指标
主要结局
Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion.
时间窗: Up to 24 weeks
次要结局
- Number and percentage of participants with serum HBsAg < LOD and/or HBV DNA < LLOQ.(Up to 72 weeks)
- The changes of liver HBsAg, HBcAg, HBV RNA, integration HBV DNA and covalently closed circular DNA (cccDNA) compared to baseline;(Up to 72 weeks)
- The changes in the phenotype of liver immune cells compared to baseline;(Up to 72 weeks)
- The changes of peripheral blood cytokines compared to baseline;(Up to 72 weeks)
- The changes of peripheral blood immune cell phenotypes compared to baseline;(Up to 72 weeks)
- The changes of serum HBsAg, HBsAb, HBV DNA, HBV RNA, HBeAg, HBeAb compared to baseline;(Up to 72 weeks)
- The changes in peripheral blood metabolomics compared to baseline;(Up to 72 weeks)
- The changes in peripheral blood proteomics compared to baseline;(Up to 72 weeks)
- The changes in liver metabolomics compared to baseline, if applicable ;(Up to 72 weeks)
- AHB-137 drug concentrations, and metabolite profiling, if applicable;(Up to 72 weeks)
- Number and percentage of participants with detectable anti-drug antibodies (ADA);(Up to 72 weeks)
- Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.(Up to 72 weeks)
- After discontinuation of all chronic hepatitis B treatments for 24 weeks, HBV DNA was below the limit of quantification (LLOQ), and HBsAg was below the detection limit (0.05 IU/mL), with HBeAg being negative, with or without the presence of HBsAg.(Up to 72 weeks.)
- After discontinuation of all chronic hepatitis B treatments for 24 weeks, HBV DNA was below the limit of quantification (LLOQ), and HBsAg was less than 10 IU/mL.(Up to 72 weeks)
- Whether the NA treatment discontinuation criteria have been met during the assessment of NA treatment discontinuation.(48 weeks)
- Proportion of participants maintaining sustained response;(Up to 48 weeks)
研究者
研究点 (2)
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