The Changes of Natural Killer Cells Frequency and Function During Antiviral Therapy
- Registration Number
- NCT03208998
- 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, NKs are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of NKs frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of NKs function, or Peg IFN - alpha enhanced NKs 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, NKs are the main effector cells in early antiviral innate 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 pDCs in the case of hepatitis and the function enhancement of NKs during Peg-IFN-α therapy. This study was aimed at investigating the changes of NKs frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of NKs function, or recovery of NKs function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage NKs function, and the loss of HBsAg and HBeAg led to recovery of NKs 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 Natural Killer Cells at baseline and at treatment week 12, 24 the changes of NK%,CD56bri/NK%,CD56dim/NK%,IFNAR2+NK%,IFNAR2MFI,NKp46+/NK%,NKp46dim/NK%,NKp46high/NK%, NKp46MFI,and NKp46ABC will be measured by flow cytometry during Pegylated Interferon α-2a and Nucleoside Analogues Treatment
- Secondary Outcome Measures
Name Time Method 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 HBV markers and HBV DNA levels and liver function
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 and HBV DNA levels and liver function
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 HBV markers and HBV DNA levels and liver function
Trial Locations
- Locations (1)
Beijing Ditan hospital,Capital Medical University
🇨🇳Beijing, Beijing, China