Research on Clinical Recovery and Maintenance Strategies for CHB
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Municipal Administration of Hospitals
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Merge with other hepatitis virus (HCV, HDV) infections;
Autoimmune liver disease;
HIV infection;
Long term alcohol abuse and/or other liver damaging drugs;
Trial design
Design model
Parallel
Treatments tested in this trial
baseline anti-HBs titer
Biological/VaccinePatients 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.
Treatment groups
285 Participants
are divided into 3 treatment groupsGroup A: Group A:baseline anti-HBs titer≥100 mIU/mlNo intervention 0 interventions
Group B: Group B:baseline anti-HBs titer<100 mIU/mlNo intervention 0 interventions
Group C: Group C:baseline anti-HBs titer<100 mIU/mlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sustained response rate and relapse rate by virological and serological indicators
The levels of biochemical, AFP, HBV DNA, HBV RNA, HBsAg, anti-HBs, HBeAg, anti-He, anti-He, HBcrAg and anti-HBc measured the expression of frequency and functional molecules of peripheral blood pDC and Treg cells and the plasma levels of IFN- γ, IP-10, IL-10 and TGF- β
Time frame
Conduct testing every 3-6 monthsSecondary outcomes
1
The incidence of hepatitis and liver cancer
The incidence of hepatitis and liver cancer among the enrolled researchers during the research process The incidence of hepatitis and liver cancer among the enrolled researchers during the research process The incidence of hepatitis and liver cancer among the enrolled researchers during the research process.
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov