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

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ClinicalTrials.gov Identifier: NCT03734783
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
LiangXS, Changhai Hospital

Brief 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.

Condition or disease
Chronic Hepatitis b

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Regulate Effect of Il-35 Secreting Breg Cells on Tcells and on Diseases Progression in Patients With CHB
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  1. IL-35+Bregs phenotype [ Time Frame: enrolled day ]
    the main phenotype of IL-35 secreting Bregs



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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis B infection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734783


Locations
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China
Changhai hospital
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital

Additional Information:

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Responsible Party: LiangXS, Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03734783     History of Changes
Other Study ID Numbers: 16ZR1400400
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LiangXS, Changhai Hospital:
chronic hepatitis B
regulating B cells
T help 17 cells
Interleukin 35
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections