Chronic Hepatitis bNCT03734783
IL-35+Breg/Il-35 Effect on T Cell Immune in Patients With CHB
An observational study of Chronic Hepatitis b, run by Changhai Hospital at 1 site in China.
Trial summary
The investigators observed the level of IL-35 secreting B regulatory (IL-35+Bregs) cells in peripheral blood cells in patients with chronic hepatitis B, and analysed the relationship between the IL-35+Bregs level and disease stage, and Th1 and Th2 cells level. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 15 Nov 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with chronic hepatitis B infection
Who may be able to join
- Clinical diagnosis of chronic hepatitis B virus infection
- 17<age<70
- Can read, understand and sign patients informed consent
Who cannot join
- Co-infection with HCV,HIV,HDV etc.
- Have malignancy
- Have uncontrollable extra-hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulate Effect of Il-35 Secreting Breg Cells on Tcells and on Diseases Progression in Patients With CHB
The investigators observed the level of IL-35 secreting B regulatory (IL-35+Bregs) cells in peripheral blood cells in patients with chronic hepatitis B, and analysed the relationship between the IL-35+Bregs level and disease stage, and Th1 and Th2 cells level.
Read the detailed description
Regulatory B cells (Bregs) are involved in the immune tolerance process through multiple pathways and Bregs are involved in the process of chronic HBV infection.
Here the investigators intended to investigate the regulating role and the mechanism of CD19+ IL-35+ cells on host T cell immune during chronic HBV infection by using in vitro cell sorting, B cell differentiation induction, Transwell cell co-culture system and other methods.
- Conditions
- Chronic Hepatitis b
- Keywords
- chronic hepatitis B, regulating B cells, T help 17 cells, Interleukin 35
- 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 |
|---|---|---|
| Patients | HBsAg positive more than 6 months | |
| health control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-35+Bregs level
IL-35 secreting regulatory B cells level in patients with CHB
Measured: ENROLLED DAY
IL-35+Bregs regulatory effect
regulatory effect of IL-35+Bregs on T cell immune
Measured: enrolled day
Secondary outcomes (1)
IL-35+Bregs phenotype
the main phenotype of IL-35 secreting Bregs
Measured: enrolled day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jul 2017
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiangXS, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734783
- Sponsor's protocol ID
- 16ZR1400400
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2018
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Y, Luo Y, Zhu T, Jiang M, Tian Z, Tang G, Liang X. Regulatory B Cells Dysregulated T Cell Function in an IL-35-Dependent Way in Patients With Chronic Hepatitis B. Front Immunol. 2021 Apr 12;12:653198. doi: 10.3389/fimmu.2021.653198. eCollection 2021.
PubMed 33912178
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulate Effect of Il-35 Secreting Breg Cells on Tcells and on Diseases Progression in Patients With CHB
- ClinicalTrials.gov ID
- NCT03734783
- Acronym / sponsor ID
- 16ZR1400400
- Conditions
- Chronic Hepatitis b
- Keywords
- chronic hepatitis B, regulating B cells, T help 17 cells, Interleukin 35
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 8 Nov 2018 (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.
The investigators observed the level of IL-35 secreting B regulatory (IL-35+Bregs) cells in peripheral blood cells in patients with chronic hepatitis B, and analysed the relationship between the IL-35+Bregs level and disease stage, and Th1 and Th2 cells level.
Detailed description
Regulatory B cells (Bregs) are involved in the immune tolerance process through multiple pathways and Bregs are involved in the process of chronic HBV infection.
Here the investigators intended to investigate the regulating role and the mechanism of CD19+ IL-35+ cells on host T cell immune during chronic HBV infection by using in vitro cell sorting, B cell differentiation induction, Transwell cell co-culture system and other methods.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –HBsAg positive more than 6 months |
| health control | – | – |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic hepatitis B infection
Key inclusion criteria (3 listed)
- Clinical diagnosis of chronic hepatitis B virus infection
- 17<age<70
- Can read, understand and sign patients informed consent
Key exclusion criteria (3 listed)
- Co-infection with HCV,HIV,HDV etc.
- Have malignancy
- Have uncontrollable extra-hepatic disease
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
IL-35+Bregs level
Time frame: ENROLLED DAY
IL-35 secreting regulatory B cells level in patients with CHB
IL-35+Bregs regulatory effect
Time frame: enrolled day
regulatory effect of IL-35+Bregs on T cell immune
1 secondary outcome
IL-35+Bregs phenotype
Time frame: enrolled day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Derived from this study: PubMed 33912178Liu Y, Luo Y, Zhu T, Jiang M, Tian Z, Tang G, Liang X. Regulatory B Cells Dysregulated T Cell Function in an IL-35-Dependent Way in Patients With Chronic Hepatitis B. Front Immunol. 2021 Apr 12;12:653198. doi: 10.3389/fimmu.2021.653198. eCollection 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis b, run by Changhai Hospital at 1 site 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 3 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: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-35+Bregs level (time frame: ENROLLED DAY). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734783, which also lists 1 linked publication.
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 18 Nov 2019.