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临床试验/NCT06803368
NCT06803368招募中不适用

Research on Clinical Recovery and Maintenance Strategies for Chronic Hepatitis B

Beijing Municipal Administration of Hospitals1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2024年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
285
试验地点
1
主要终点
Sustained response rate and relapse rate by virological and serological indicators

研究概览

简要总结

Collect basic information of patients before antiviral treatment and when HBsAg disappears, and divide them into three groups A, B, and C based on baseline anti HBs titers after informed consent. During the follow-up period of all patients, clinical biochemistry, virology (HBVDNA, HBVRNA), serological indicators (HBsAg, anti HBs, HBeAg, anti HBe, HBcrAg, anti HBc), AFP, Fibroscan, liver imaging examinations will be conducted every 3-6 months, and blood samples will be retained for monitoring the frequency of immune cells (pDC, Treg) and the expression of functional molecules, as well as cytokines (IFN - γ, IP-10, IL-10, and TGF - β). Observe the sustained response rate and recurrence rate of virological and serological indicators, as well as the incidence of hepatitis and liver cancer during the follow-up period.

详细描述

Collect basic information of patients before antiviral treatment and when HBsAg disappears, and divide them into three groups A, B, and C based on baseline anti HBs titers after informed consent. Group A has an anti HBs titer ≥ 100mIU/ml and is followed up every 3-6 months for observation. The anti HBs titers<100mIU/ml were randomly divided into two groups: Group B and Group C. Group B did not intervene and was followed up every 3-6 months for observation; In group C, 20 micrograms of recombinant hepatitis B vaccine were injected subcutaneously three times on day 0, January and March. For group C patients, the level of anti HBs was detected at the 4th month after the initial vaccination. For those who could not produce anti HBs (anti HBs<10mIU/ml), the recombinant hepatitis B vaccine was subcutaneously injected three times, 20 μ g each time, in 0 day, January and March. During the follow-up period of all patients, clinical biochemistry, virology (HBVDNA, HBVRNA), serological indicators (HBsAg, anti HBs, HBeAg, anti HBe, HBcrAg, anti HBc), AFP, Fibroscan, liver imaging examinations were conducted every 3-6 months, and blood samples were retained for monitoring the frequency of immune cells (pDC, Treg) and the expression of functional molecules, as well as cytokines (IFN - γ, IP-10, IL-10, and TGF - β). Observe the sustained response rate and recurrence rate of virological and serological indicators, as well as the incidence of hepatitis and liver cancer during the follow-up period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • •Age between 18 and 65 years old;
  • •Gender is not limited;
  • •CHB patients who meet the diagnostic criteria of the 2019 edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B [5];
  • •Confirmed interferon treatment resulted in HBsAg disappearance, HBeAg negativity, and HBV DNA below the lower detection limit and cessation Patients treated with interferon;
  • •Sign a written informed consent form.

排除标准

  • •Merge with other hepatitis virus (HCV, HDV) infections;
  • •Autoimmune liver disease;
  • •HIV infection;
  • •Long term alcohol abuse and/or other liver damaging drugs;
  • •Mental illness;
  • •Evidence of liver tumors (liver cancer or AFP>100ng/ml);
  • •Decompensated cirrhosis;
  • •Individuals with serious diseases of the heart, brain, lungs, kidneys, and other systems who cannot participate in long-term follow-up.

研究组 & 干预措施

Group C:baseline anti-HBs titer<100 mIU/ml

Experimental

Patients with anti-HBs titer<100 mIU/ml at baseline were randomly divided into group B and group C, and group C received hepatitis B vaccine injection.

干预措施: baseline anti-HBs titer (Biological)

结局指标

主要结局

Sustained response rate and relapse rate by virological and serological indicators

时间窗: Conduct testing every 3-6 months

The levels of biochemical, AFP, HBV DNA, HBV RNA, HBsAg, anti-HBs, HBeAg, anti-He, anti-He, HBcrAg and anti-HBc measured the expression of frequency and functional molecules of peripheral blood pDC and Treg cells and the plasma levels of IFN- γ, IP-10, IL-10 and TGF- β

次要结局

  • The incidence of hepatitis and liver cancer(36 months)

研究者

发起方
Beijing Municipal Administration of Hospitals
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Minghui Li

Head of Department

Beijing Municipal Administration of Hospitals

研究点 (1)

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