Clinical trial NCT06803368: Research on Clinical Recovery and Maintenance Strategies for CHB
Official title: Research on Clinical Recovery and Maintenance Strategies for Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Hepatitis b
Hepatitis B Vaccine
Lead sponsor: Beijing Municipal Administration of Hospitals
Sponsor class: OTHER_GOV
First posted: 2025-01-31
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sustained response rate and relapse rate by virological and serological indicators
timeFrame: Conduct testing every 3-6 months
Secondary outcomes:
measure: The incidence of hepatitis and liver cancer
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital
name: Minghui Li
role: PRINCIPAL_INVESTIGATOR
References: