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Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B

2026年9月2日 更新者：Beijing 302 Hospital

Safety and Efficacy of Sequential Treatment With a PD-1 Antibody and Pegylated Interferon-α in Nucleos(t)Ide Analogue-Suppressed Patients With Chronic Hepatitis B

This is a prospective, multicenter, randomized, open-label controlled clinical trial designed to evaluate the efficacy and safety of a sequential treatment strategy incorporating a PD-1 antibody and pegylated interferon-α (Peg-IFNα) in patients with chronic hepatitis B receiving stable nucleos(t)ide analogue (NA) therapy.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

A total of 60 participants will be randomly assigned in a 1:1 ratio to an experimental group or a control group. Participants in the experimental group will initially receive a PD-1 antibody in combination with continued NA therapy, followed by a period of triple therapy with the PD-1 antibody, Peg-IFNα, and NAs. The PD-1 antibody will then be discontinued, while Peg-IFNα plus NAs will be continued through Week 48. Participants in the control group will receive Peg-IFNα plus continued NA therapy from baseline through Week 48.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

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

学习地点

  • 中国
      • Jinan、中国
        • Shandong Public Health Clinical Center
        • 接触：
          • Xiaoying Li
      • Taiyuan、中国
        • The Third People's Hospital of Taiyuan
        • 接触：
          • Ying Guo
      • Xi'an、中国
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • 接触：
          • Tianyan Chen
      • Xi'an、中国
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • 接触：
          • Mei Li

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

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • 1. Aged 18-55 years;
  • 2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
  • 3. Treatment with NAs(ETV, TDF or TAF)at least 1 years and continue NAs therapy during screening;
  • 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 500IU/ml .

Exclusion Criteria:

  • 1. Cirrhosis;
  • 2.platelet count < 90×10^9/L, WBC count < 3.0×10^9/L, ALT /AST> ULN (40U/L), total bilirubin > 2ULN;
  • 3.History of or suspicion of hepatocellular carcinoma
  • 4.Patients received interferon therapy within 6 months;
  • 5.Patients received immunosuppressive therapy or other therapy influenced study within 6 months;
  • 6.Pregnancy
  • 7.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
  • 8.Presence of severe uncontrolled diseases of respiratory, cardiovascular or other organ systems;
  • 9.Alcohol or drug abuse/dependence;
  • 10.Other conditions rendering subjects ineligible for enrollment, including but not limited to absolute contraindications to interferon therapy, known hypersensitivity to any study drug or their excipients, and anticipated poor compliance with treatment and follow-up procedures.

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
实验性的：Sequential PD-1 Antibody and Peg-IFNα
Participants will continue background nucleos(t)ide analogue therapy throughout the study. During Weeks 0-12, participants will receive the PD-1 antibody plus NAs. Peg-IFNα will be added at Week 12, resulting in triple therapy with the PD-1 antibody, Peg-IFNα, and NAs during Weeks 12-24. After completion of PD-1 antibody treatment at Week 24, participants will continue Peg-IFNα plus NAs through Week 48.
药品：Sintilimab
Sintilimab will be administered intravenously at a dose of 1.0 mg/kg at Weeks 0, 6, 12, and 18, for a total of four doses.
药品：Pegylated Interferon-α 2b

Peg-IFNα will be administered subcutaneously once weekly from Week 12 through Week 48.

Dose: 135 μg or 180 μg, according to the study protocol. When sintilimab and Peg-IFNα are scheduled during the same treatment period, administration of the two drugs will be separated by at least 72 hours.

药品：Nucleos(t)ide Analogues
Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.
其他名称：
  • TDF
  • 教育电视
  • 塔夫
药品：Pegylated Interferon-α 2b

Peg-IFNα will be administered subcutaneously once weekly from Week 0 through Week 48.

Dose: 135 μg or 180 μg, according to the study protocol.
有源比较器：Peg-IFNα
Participants will receive Peg-IFNα in combination with continued background nucleos(t)ide analogue therapy from baseline through Week 48.
药品：Pegylated Interferon-α 2b

Peg-IFNα will be administered subcutaneously once weekly from Week 12 through Week 48.

Dose: 135 μg or 180 μg, according to the study protocol. When sintilimab and Peg-IFNα are scheduled during the same treatment period, administration of the two drugs will be separated by at least 72 hours.

药品：Nucleos(t)ide Analogues
Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.
其他名称：
  • TDF
  • 教育电视
  • 塔夫
药品：Pegylated Interferon-α 2b

Peg-IFNα will be administered subcutaneously once weekly from Week 0 through Week 48.

Dose: 135 μg or 180 μg, according to the study protocol.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The rate of patients with HBsAg loss at Weeks 24 and 48
大体时间：48weeks
48weeks
Incidence of treatment-emergent adverse events/serious adverse events
大体时间：48weeks
48weeks

次要结果测量

结果测量
措施说明
大体时间
The rate of patients with HBsAg decline > 1log(IU/ml) at Weeks 24 and 48
大体时间：48 weeks
48 weeks
The rate of patients with HBsAb positive at Weeks 24 and 48.
大体时间：48 weeks
48 weeks
The concentration of HBcrAg at baseline, at weeks 12, 24 and 48.
大体时间：48 weeks
Evaluate the level of serum HBcrAg at baseline, at weeks 12,24 and 48.
48 weeks
The concentration of pgRNA at baseline, at weeks 12,24 and 48.
大体时间：48 weeks
Evaluate the level of serum pgRNA at baseline, at weeks 12,24 and 48.
48 weeks
The concentration of anti-HBc at baseline, at weeks 12,24 and 48.
大体时间：48 weeks
Evaluate the level of serum anti-HBc at baseline, at weeks 12,24 and 48.
48 weeks
Frequency and function of peripheral T-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot, at weeks 12,24 and 48.
大体时间：48 weeks
The frequency (unit: percentage of peripheral lymphocytes) and function of peripheral T-lymphocytes will be evaluated using flow cytometry, FluoroSpot, and ELISpot assays.
48 weeks
Frequency and function of peripheral B-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot,at weeks 12,24 and 48.
大体时间：48 Weeks
The frequency (unit: percentage of peripheral lymphocytes) and function of peripheral B-lymphocytes will be evaluated using flow cytometry, FluoroSpot, and ELISpot assays.
48 Weeks
Frequency and function of peripheral NK-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot at weeks 12,24 and 48.
大体时间：48 weeks
The frequency (unit: percentage of peripheral lymphocytes) and function of peripheral NK-lymphocytes will be evaluated using flow cytometry.
48 weeks

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。

赞助

Beijing 302 Hospital

调查人员

  • 首席研究员：Junliang Fu、Beijing 302 Hospital

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9月1日

初级完成 (估计的)

2029年9月1日

研究完成 (估计的)

2029年9月1日

研究注册日期

首次提交

2026年8月25日

首先提交符合 QC 标准的

2026年9月2日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • KY-2026-7-122-2

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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