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

Chronic Hepatitis b Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734783
• Other study ID #: 16ZR1400400
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: November 15, 2019

Study information

• Verified date: November 2019
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-35+Bregs level	IL-35 secreting regulatory B cells level in patients with CHB	ENROLLED DAY
Primary	IL-35+Bregs regulatory effect	regulatory effect of IL-35+Bregs on T cell immune	enrolled day
Secondary	IL-35+Bregs phenotype	the main phenotype of IL-35 secreting Bregs	enrolled day