NCT06803368

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Nov 2024Oct 2027

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

January 26, 2025

Last Update Submit

January 26, 2025

Conditions

Chronic Hepatitis bHepatitis B Vaccine

Outcome Measures

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

    Conduct testing every 3-6 months

Secondary Outcomes (1)

  • The incidence of hepatitis and liver cancer

    36 months

Study Arms (3)

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

NO INTERVENTION

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

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

NO INTERVENTION

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

EXPERIMENTAL

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.

Biological: baseline anti-HBs titer

Interventions

baseline anti-HBs titerBIOLOGICAL

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.

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Minghui Li

    Beijing Ditan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Zhang

CONTACT

13581975577zhanglu1218@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

January 26, 2025

First Posted

January 31, 2025

Study Start

November 1, 2024

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2027

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations

CN(1)