Research on Clinical Recovery and Maintenance Strategies for CHB

Beijing Municipal Administration of Hospitals

Status: Enrolling

Conditions: Chronic Hepatitis b; Hepatitis B Vaccine

Treatments: Biological: baseline anti-HBs titer

Study type: Interventional

Funder types: Other

Identifiers

NCT06803368

BRWEP2024W102170101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 285 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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285 participants in 3 patient groups

Group A:baseline anti-HBs titer≥100 mIU/ml

No Intervention group

Description:

Patients with anti-HBs titer ≥100 mIU/ml at baseline were selected as group A

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

No Intervention group

Description:

Patients with anti-HBs titer\<100 mIU/ml at baseline were randomly divided into group B and group C, and group B did not receive intervention

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

Experimental group

Description:

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.

Treatment:

Biological: baseline anti-HBs titer