The Changes of Cytokines During Antiviral Therapy

Not Applicable

• Conditions: Chronic Hepatitis B Infection
• Interventions: Drug: Peginterferon Alfa-2a

• Registration Number: NCT03210506
• 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, cytokines played a vital role. This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α therapy resulted in the secretion of cytokines.

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, cytokines including Fit-3L, IFN-alpha2, IFN-gama, IL-10, IL-17A,IL-2, IL-6, TNF-alpha, TGF-beta1, TGF-beta2,TGF-beta3, played a vital role.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 might be related to the increase of cytokine secretion in the case of hepatitis and during Peg-IFN-α therapy.This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to clarify whether Peg-IFN-α therapy led to the secretion of cytokines.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-12
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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 cytokines	after treatment 24 weeks	the changes of cytokines levels will be measured by Luminex test after Pegylated Interferon α-2a and entecavir((ETV) Treatment 24 weeks.

Secondary Outcome Measures

Name	Time	Method
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 HBVDNA levels (IU/ML)	afte treatment 48 weeks	the curative effect of antiviral therapy will be evaluated by HBV DNA 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
the change of HBsAg levels (IU/ML)	afte treatment 48 weeks	the curative effect of antiviral therapy will be evaluated by HBsAg levels

Trial Locations

Locations (1)

Beijing Ditan hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China