ACT201 Injection in Participants With Chronic Hepatitis B (CHB) on Nucleos(t)Ide Analog Therapy - Phase Ib
2026年11月4日 更新者：Xiamen Amoytop Biotech Co., Ltd.
A Multicenter, Randomized, Open-label Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of ACT201 Injection in Participants With Chronic Hepatitis B (CHB) Receiving Nucleos(t)Ide Analog Therapy
This is a multicenter, randomized, open-label, parallel-controlled Phase Ib clinical trial. It aims to evaluate the safety and preliminary efficacy of ACT201 Injection combined with standard therapy (PegIFNα, NA) in participants with chronic hepatitis B who are receiving NA treatment. A total of 40 participants with chronic hepatitis B will be enrolled. Eligible participants should have stable NA treatment, HBV DNA < 100 IU/mL, negative HBeAg, and HBsAg ≤ 100 IU/mL. They will be randomized into four treatment groups at a 1:1:1:1 ratio.
研究概览
研究类型
介入性
注册 (估计的)
40
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xiulan Xue, Ph.D
- 电话号码：13666061349
- 邮箱：xuexiulan2003@126.com
学习地点
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-
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Beijing、中国
- Beijing Ditan Hospital, Capital Medical University
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接触：
- Minghui Li
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Wuhan、中国
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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接触：
- Qin Ning
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Xi'an、中国
- The Second Affiliated Hospital of Xi'an Jiaotong University
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接触：
- Shuangsuo Dang
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Xiamen、中国
- The First Affiliated Hospital of Xiamen University
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接触：
- Xiulan Xue
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Voluntarily participate in this trial and sign the informed consent form;
- Aged 18 to 65 years (inclusive), male or female;
- Body mass index (BMI) ranging from 18 to 32 kg/m² (inclusive);
- HBsAg-positive or HBV DNA-positive for at least 6 months, or with prior liver biopsy results consistent with chronic HBV infection, or HBsAg-positive and anti-HBc IgM-negative at screening;
- Receiving stable nucleos(t)ide analogue (NA) therapy at screening;
- Meeting the specified requirements for HBsAg, HBeAg, HBV DNA and liver function parameters;
- Willing to use effective contraception with no plan to conceive, donate sperm or donate ova.
Exclusion Criteria:
- Subjects who have sustained major trauma or undergone major surgery recently, or have a planned surgery;
- Subjects with uncontrolled, clinically significant abnormalities or other severe illnesses in addition to chronic HBV infection;
- Subjects with a history of other liver diseases;
- Subjects with a history of liver cirrhosis;
- Subjects with imaging findings suggestive of a suspected malignant hepatic lesion;
- Subjects with prior or current manifestations of hepatic decompensation;
- Subjects with a history of extrahepatic diseases potentially associated with HBV immune status;
- Subjects with other diseases associated with vasculitis;
- Subjects with infections (other than HBV) requiring systemic antiviral or antibacterial therapy at screening;
- Subjects with a history of malignancy;
- Subjects with prior solid organ or bone marrow transplantation;
- Subjects with current or past history of severe psychiatric disorders;
- Subjects with severe retinopathy or other severe ophthalmologic diseases;
- Subjects who have received prohibited study drugs previously or currently;
- Subjects with concomitant hematological diseases;
- Subjects with abnormal laboratory findings;
- Subjects with abnormal QTcF interval;
- Subjects with a history of allergy;
- Subjects who are breastfeeding or have a positive serum pregnancy test at screening;
- Subjects participating in another clinical trial, or those who have not completed the washout period specified in the protocol prior to this trial;
- Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in this trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：第 2 组
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Subcutaneous injection per assigned dose group; treatment duration shall follow the study protocol.
其他名称：
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实验性的：第 1 组
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Subcutaneous injection per assigned dose group; treatment duration shall follow the study protocol.
其他名称：
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实验性的：第 3 组
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Subcutaneous injection per assigned dose group; treatment duration shall follow the study protocol.
其他名称：
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实验性的：第 4 组
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Subcutaneous injection per assigned dose group; treatment duration shall follow the study protocol.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results. Assessments include vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs).
大体时间：throughout the full study period,an average of 38 weeks
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throughout the full study period,an average of 38 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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HBsAg, HBsAb and HBV DNA levels and changes from baseline
大体时间：throughout the full study period,an average of 38 weeks
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throughout the full study period,an average of 38 weeks
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HBsAg seroclearance rate
大体时间：throughout the full study period,an average of 38 weeks
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throughout the full study period,an average of 38 weeks
|
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HBsAg seroconversion rate
大体时间：throughout the full study period,an average of 38 weeks
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throughout the full study period,an average of 38 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xiulan Xue、The First Affiliated Hospital of Xiamen University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月20日
初级完成 (估计的)
2027年2月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年11月4日
首先提交符合 QC 标准的
2026年11月4日
首次发布 (实际的)
2026年11月10日
研究记录更新
最后更新发布 (实际的)
2026年11月10日
上次提交的符合 QC 标准的更新
2026年11月4日
最后验证
2026年11月1日
更多信息
与本研究相关的术语
其他研究编号
- ACT201-4-1-005
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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