The Changes of CD8+T Cells Frequency and Function During Antiviral Therapy
- Registration Number
- NCT03209037
- 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, CD8+T cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.
- 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, CD8+T cells are the main effector cells in adaptive immune response.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 CD8+T cells in the case of hepatitis and the function enhancement of CD8+T cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD8+T cells function, or recovery of CD8+T cells function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage CD8+T cells function, and the loss of HBsAg and HBeAg led to recovery of CD8+T cells function.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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 CD8+T Cells at baseline and at treatment week 12, 24. the changes of CD8+T cells%, CD69+CD8+T cells%, CD69MFI, CD69ABC, CD178+CD8+T cells%, CD178MFI, CD178ABC,IFN-AR2+CD8+T cells%, IFNAR2MFI, IFNAR2ABC will be measured by flow cytometry during Pegylated Interferon α-2a and Nucleoside Analogues Treatment every 3 months.
- Secondary Outcome Measures
Name Time Method the change of HBVDNA levels (IU/ML) at baseline and at treatment 12, 24, 36, 48 weeks the curative effect of antiviral therapy will be evaluated by HBV markers
the change of ALT levels(U/L) at baseline and at treatment 12, 24, 36, 48 weeks the curative effect of antiviral therapy will be evaluated by ALT levels
the change of AST levels(U/L) at baseline and at treatment 12, 24, 36, 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