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Research on Clinical Recovery and Maintenance Strategies for CHB

NCT ID: NCT06803368

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-10-30

Brief Summary

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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.

Detailed Description

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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. Group A has an anti HBs titer ≥ 100mIU/ml and is followed up every 3-6 months for observation. The anti HBs titers\<100mIU/ml were randomly divided into two groups: Group B and Group C. Group B did not intervene and was followed up every 3-6 months for observation; In group C, 20 micrograms of recombinant hepatitis B vaccine were injected subcutaneously three times on day 0, January and March. For group C patients, the level of anti HBs was detected at the 4th month after the initial vaccination. For those who could not produce anti HBs (anti HBs\<10mIU/ml), the recombinant hepatitis B vaccine was subcutaneously injected three times, 20 μ g each time, in 0 day, January and March. 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 were conducted every 3-6 months, and blood samples were 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

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Chronic Hepatitis b Hepatitis B Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A:baseline anti-HBs titer≥100 mIU/ml

Patients with anti-HBs titer ≥100 mIU/ml at baseline were selected as group A

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B:baseline anti-HBs titer<100 mIU/ml

Patients with anti-HBs titer\<100 mIU/ml at baseline were randomly divided into group B and group C, and group B did not receive intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Group C:baseline anti-HBs titer<100 mIU/ml

Patients with anti-HBs titer\<100 mIU/ml at baseline were randomly divided into group B and group C, and group C received hepatitis B vaccine injection.

Group Type EXPERIMENTAL

baseline anti-HBs titer

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Administration of Hospitals

OTHER_GOV

Sponsor Role lead

Responsible Party

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Minghui Li

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Minghui Li

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Locations

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Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lu Zhang

Role: CONTACT

Phone: 13581975577

Email: [email protected]

Facility Contacts

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Lu Zhang

Role: primary

Other Identifiers

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BRWEP2024W102170101

Identifier Type: -

Identifier Source: org_study_id