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NCT Number: NCT03734783

IL-35+Breg/Il-35 Effect on T Cell Immune 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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai hospital

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. IL-35+Bregs level

    Time frame: ENROLLED DAY

    IL-35 secreting regulatory B cells level in patients with CHB

  2. IL-35+Bregs regulatory effect

    Time frame: enrolled day

    regulatory effect of IL-35+Bregs on T cell immune

Secondary outcomes

  1. IL-35+Bregs phenotype

    Time frame: enrolled day

    the main phenotype of IL-35 secreting Bregs

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Regulate Effect of Il-35 Secreting Breg Cells on Tcells and on Diseases Progression in Patients With CHB

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2018
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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