Research on Clinical Recovery and Maintenance Strategies for CHB

NCT06803368 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2025-01-31

No results posted yet for this 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.

Conditions

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06803368 on ClinicalTrials.gov