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NCT06525909Recruiting

A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B

Source: ClinicalTrials.gov · Last updated 29 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
24 Jul 2024
Start date
Jan 2024
Primary completion date
Dec 2026
Lead sponsor
Tongji Hospital
Diseases
Hepatitis B
NCT number
NCT06525909

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From Jan 2024 to the primary completion date, Dec 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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);

Other illness

  • Combined HAV, HCV, HEV infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, HIV infection;
  • 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;

Lab values

  • Inadequate follow-up time and inadequate clinical/laboratory information;

Other

  • Pregnancy status;
  • Has been diagnosed with compensated/lost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators;
  • Unwilling to participate in this study.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing YouAn Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
The First Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaNot yet recruiting
Southwest Hospital
Coordinator of this site? Confirm its status
ChongqingChinaNot yet recruiting
Jiangsu Province Hospital
Coordinator of this site? Confirm its status
NanjingChinaNot yet recruiting
Tongji Hospital
Coordinator of this site? Confirm its status
WuhanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.