The Changes of Treg Cells Frequency and Function During Antiviral Therapy
- Registration Number
- NCT03210493
- Lead Sponsor
- Beijing Ditan Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group Peginterferon Alfa-2a 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.
- Primary Outcome Measures
Name Time Method the changes of Treg Cells after treatment 24 weeks. Treg Cells will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24weeks.
- Secondary Outcome Measures
Name Time Method the change of HBsAg levels (IU/ML) afte treatment 48 weeks the curative effect of antiviral therapy will be evaluated by HBsAg levels
the change of HBVDNA levels (IU/ML) afte treatment 48 weeks the curative effect of antiviral therapy will be evaluated by HBV DNA levels
the change of HBeAg levels (IU/ML) afte treatment 48 weeks the curative effect of antiviral therapy will be evaluated by HBeAg levels
the change of ALT levels(U/L) afte treatment 48 weeks the curative effect of antiviral therapy will be evaluated by ALT levels
the change of AST levels(U/L) afte treatment 48 weeks the curative effect of antiviral therapy will be evaluated by AST levels
Trial Locations
- Locations (1)
Beijing Ditan hospital,Capital Medical University
🇨🇳Beijing, Beijing, China