Hepatitis B, ChronicNCT06525909
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
An observational study of Hepatitis B, Chronic, run by Tongji Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 250 participants
- Where
- 5 sitesChina
- Study dates
- 20 Jan 2024to 10 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: the patients with Chronic Hepatitis B
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing YouAn Hospital
Beijing
Wei Hou
- Not yet recruiting
The First Hospital of Jilin University
Changchun
Junqi Niu
- Not yet recruiting
Southwest Hospital
Chongqing
Qing Mao
- Not yet recruiting
Jiangsu Province Hospital
Nanjing
Chuanlong Zhu
- Recruiting
Tongji Hospital
Wuhan, Hubei
Qin Ning, Doctor, 02783662391, qning@vip.sina.com
Meifang Han, 02783662391, mfhan@foxmail.com
About this study
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.
Read the detailed description
Two groups were included in this study: untreated patients who met the staging subgroups according to Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022 edition or HBsAg negativity（Group 1). The another is those who achieved HBV DNA suppression by NA（Group 2）. Patients in Group 1 will be followed up once every six months, and in group 2 will be followed up once every three months. And patients treated or not treated will be followed up in the study. The treatment with NA or combined with interferon will be decided by the consensus of doctors and patients. This study does not intervene the treatment, but will register the clinical indicators. We follow up the patients at each follow-up time point, record the subjects' clinical indicators at each visit and obtained serum and PBMC specimens for further immune study after the consents of the patients.
- Conditions
- Hepatitis B, Chronic
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 200
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start20 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Ning, Doctor, Principal investigator, Department of infectious Diseases, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525909
- Sponsor's protocol ID
- OCEAN cure 06 study
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT06525909
- Acronym / sponsor ID
- OCEAN cure 06 study
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two groups were included in this study: untreated patients who met the staging subgroups according to Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022 edition or HBsAg negativity（Group 1). The another is those who achieved HBV DNA suppression by NA（Group 2）. Patients in Group 1 will be followed up once every six months, and in group 2 will be followed up once every three months. And patients treated or not treated will be followed up in the study. The treatment with NA or combined with interferon will be decided by the consensus of doctors and patients. This study does not intervene the treatment, but will register the clinical indicators. We follow up the patients at each follow-up time point, record the subjects' clinical indicators at each visit and obtained serum and PBMC specimens for further immune study after the consents of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- the patients with Chronic Hepatitis B
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A preliminary exploration of staging and grading criteria for the state of immune
Time frame: week 200
The clinical characteristics, viral load and immune cells frequency (CD4+ or CD8+ T cells, etc) of CHB in different clinical stages will be studied.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qin Ning, Doctor principal investigator
Department of infectious Diseases, Tongji Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Tongji Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qin Ning, Doctor (862783662391, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A preliminary exploration of staging and grading criteria for the state of immune (time frame: week 200). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.