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The Changes of Treg Cells Frequency and Function During Antiviral Therapy

Primary Purpose

Chronic Hepatitis B Infection

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Peginterferon Alfa-2a
Sponsored by
Beijing Ditan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B Infection focused on measuring chronic hepatitis B, hepatitis B virus, Treg Cells, Pegylated Interferon α-2a, Nucleoside Analogues

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled.

Exclusion Criteria:

  • Active consumption of alcohol and/or drugs
  • Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
  • History of autoimmune hepatitis
  • Psychiatric disease
  • Evidence of neoplastic diseases of the liver

Sites / Locations

  • Beijing Ditan hospital,Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

patients who were untreated ever in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly till 48 weeks.

patients who were untreated ever in immune-active phase took Nucleoside Analogues for maintenance treatment.

Outcomes

Primary Outcome Measures

the changes of Treg Cells
Treg Cells will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24weeks.

Secondary Outcome Measures

the change of HBVDNA levels (IU/ML)
the curative effect of antiviral therapy will be evaluated by HBV DNA levels
the change of ALT levels(U/L)
the curative effect of antiviral therapy will be evaluated by ALT levels
the change of AST levels(U/L)
the curative effect of antiviral therapy will be evaluated by AST levels
the change of HBsAg levels (IU/ML)
the curative effect of antiviral therapy will be evaluated by HBsAg levels
the change of HBeAg levels (IU/ML)
the curative effect of antiviral therapy will be evaluated by HBeAg levels

Full Information

First Posted
July 3, 2017
Last Updated
July 10, 2017
Sponsor
Beijing Ditan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03210493
Brief Title
The Changes of Treg Cells Frequency and Function During Antiviral Therapy
Official Title
The Changes of Treg Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Ditan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, Treg cells Regulatory T cells played a negative role in immune. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.
Detailed Description
Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, Treg cells play an important role in immune regulation.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of Treg cells in the case of hepatitis and the function enhancement of Treg cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B Infection
Keywords
chronic hepatitis B, hepatitis B virus, Treg Cells, Pegylated Interferon α-2a, Nucleoside Analogues

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
patients who were untreated ever in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly till 48 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients who were untreated ever in immune-active phase took Nucleoside Analogues for maintenance treatment.
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2a
Other Intervention Name(s)
Peg-IFN-α
Intervention Description
patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group
Primary Outcome Measure Information:
Title
the changes of Treg Cells
Description
Treg Cells will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24weeks.
Time Frame
after treatment 24 weeks.
Secondary Outcome Measure Information:
Title
the change of HBVDNA levels (IU/ML)
Description
the curative effect of antiviral therapy will be evaluated by HBV DNA levels
Time Frame
afte treatment 48 weeks
Title
the change of ALT levels(U/L)
Description
the curative effect of antiviral therapy will be evaluated by ALT levels
Time Frame
afte treatment 48 weeks
Title
the change of AST levels(U/L)
Description
the curative effect of antiviral therapy will be evaluated by AST levels
Time Frame
afte treatment 48 weeks
Title
the change of HBsAg levels (IU/ML)
Description
the curative effect of antiviral therapy will be evaluated by HBsAg levels
Time Frame
afte treatment 48 weeks
Title
the change of HBeAg levels (IU/ML)
Description
the curative effect of antiviral therapy will be evaluated by HBeAg levels
Time Frame
afte treatment 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled. Exclusion Criteria: Active consumption of alcohol and/or drugs Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus History of autoimmune hepatitis Psychiatric disease Evidence of neoplastic diseases of the liver
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Xie, MD
Phone
8610-84322489
Email
xieyao00120184@sina.com
Facility Information:
Facility Name
Beijing Ditan hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Xie, doctor
Phone
8613501093293
Email
xieyao00120184@sina.com
First Name & Middle Initial & Last Name & Degree
Yao Xie, doctor

12. IPD Sharing Statement

Learn more about this trial

The Changes of Treg Cells Frequency and Function During Antiviral Therapy

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