Research on Clinical Recovery and Maintenance Strategies for CHB
NCT06803368 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285
Last updated 2025-01-31
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.
Conditions
- Chronic Hepatitis b
- Hepatitis B Vaccine
Interventions
- BIOLOGICAL
-
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.
Sponsors & Collaborators
-
Beijing Municipal Administration of Hospitals
lead OTHER_GOV
Principal Investigators
-
Minghui Li · Beijing Ditan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-01
- Primary Completion
- 2027-10-30
- Completion
- 2027-10-30
Countries
- China
Study Locations
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