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
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing YouAn Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Not yet recruiting |
| Southwest Hospital Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.