IL-35+Breg/Il-35 Effect on T Cell Immune in Patients With CHB

November 15, 2019 updated by: LiangXS, Changhai Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hepatitis B infection

Description

Inclusion Criteria:

  • Clinical diagnosis of chronic hepatitis B virus infection
  • 17<age<70
  • Can read, understand and sign patients informed consent

Exclusion Criteria:

  • Co-infection with HCV,HIV,HDV etc.
  • Have malignancy
  • Have uncontrollable extra-hepatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
HBsAg positive more than 6 months
health control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-35+Bregs level
Time Frame: ENROLLED DAY
IL-35 secreting regulatory B cells level in patients with CHB
ENROLLED DAY
IL-35+Bregs regulatory effect
Time Frame: enrolled day
regulatory effect of IL-35+Bregs on T cell immune
enrolled day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-35+Bregs phenotype
Time Frame: enrolled day
the main phenotype of IL-35 secreting Bregs
enrolled day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16ZR1400400

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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