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Clinical Trials in China / NCT06803368
Recruiting Not applicable

Research on Clinical Recovery and Maintenance Strategies for CHB

NCT06803368 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Municipal Administration of Hospitals
Phase
Not applicable
Started
2024-11-01
Last updated
2025-01-31

Condition(s) studied

Chronic Hepatitis bHepatitis B Vaccine

Investigational drug(s) / intervention(s)

baseline anti-HBs titer

baseline anti-HBs titer: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Ditan Hospital Beijing Beijing Municipality Recruiting

More Beijing Municipal Administration of Hospitals trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06803368 on ClinicalTrials.gov ↗ ← All trials in China