NCT06525909

Brief Summary

This is a prospective, multicentre observational study of Chronic Hepatitis B （CHB）in different clinical stages. We intend to compare the immune status of various types of CHB patients, and we propose to establish a staging and grading criteria for the immune exhaustion status of patients with CHB.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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 Progress47%
Jan 2024Dec 2028

Study Start

First participant enrolled

January 20, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2028

Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

July 24, 2024

Last Update Submit

July 24, 2024

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • A preliminary exploration of staging and grading criteria for the state of immune

    The clinical characteristics, viral load and immune cells frequency (CD4+ or CD8+ T cells, etc) of CHB in different clinical stages will be studied.

    week 200

Study Arms (2)

Untreated group

The untreated patients who met the staging subgroups of the Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022 edition or lost HBsAg spontaneously.

NA treatment group

The patients who achieved HBV DNA suppression by NA.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

the patients with Chronic Hepatitis B

You may qualify if:

  • Patients with CHB who were older than 18 years old and younger than 50 years old with HBsAg positivity more than 6 months;
  • Group 1 untreated group fulfils any one of the four natural history types of the Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022.
  • Group 2 nucleos(t)ide-treated CHB patients are required to have sustained control of their HBV DNA (\<100 IU/ml).

You may not qualify if:

  • Pregnancy status;
  • Has been diagnosed with compensated/lost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators;
  • Combined HAV, HCV, HEV infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, HIV infection;
  • Being on immunosuppressants or immunomodulators or hormonal drugs or biological agents, etc;
  • previous history of oncology, organ transplantation, etc., history of alcoholism (\>30 g/d for men, \>20 g/d for women);
  • Inadequate follow-up time and inadequate clinical/laboratory information;
  • Combined heart, brain, kidney, lung and other organ insufficiency or combined endocrine and haematological system and other major diseases;
  • Comorbid serious psychiatric diseases including severe anxiety or depression;
  • Unwilling to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Beijing YouAn Hospital

Beijing, China

RECRUITING

The First Hospital of Jilin University

Changchun, China

NOT YET RECRUITING

Southwest Hospital

Chongqing, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Qin Ning, Doctor

    Department of infectious Diseases, Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qin Ning, Doctor

CONTACT

862783662391qning@vip.sina.com

Meifang Han, Doctor

CONTACT

862783662391mfan@foxmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Chair of Department of Infectious Diseases

Study Record Dates

First Submitted

July 24, 2024

First Posted

July 29, 2024

Study Start

January 20, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 10, 2028

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations

CN(5)