Research on Clinical Recovery and Maintenance Strategies for CHB
Research on Clinical Recovery and Maintenance Strategies for Chronic Hepatitis B
Beijing Municipal Administration of Hospitals
285 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
Patients with baseline anti-HBs titer\<100 mIU/ml were randomly divided into two groups, group B and group C. Group B did not intervene, while group C received hepatitis B vaccine intervention and observed its indicators.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06803368