The Changes of Treg Cells Frequency and Function During Antiviral Therapy

Chronic Hepatitis B Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03210493
• Other study ID #: DTXY015
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2017
• Last updated: July 10, 2017
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Beijing Ditan Hospital
• Contact: Yao Xie, MD
• Phone: 8610-84322489
• Email: xieyao00120184[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B Infection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon Alfa-2a
patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group

Locations

Country	Name	City	State
China	Beijing Ditan hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the changes of Treg Cells	Treg Cells will be measured by flow cytometry after Pegylated Interferon a-2a and entecavir(ETV) Treatment 24weeks.	after treatment 24 weeks.
Secondary	the change of HBVDNA levels (IU/ML)	the curative effect of antiviral therapy will be evaluated by HBV DNA levels	afte treatment 48 weeks
Secondary	the change of ALT levels(U/L)	the curative effect of antiviral therapy will be evaluated by ALT levels	afte treatment 48 weeks
Secondary	the change of AST levels(U/L)	the curative effect of antiviral therapy will be evaluated by AST levels	afte treatment 48 weeks
Secondary	the change of HBsAg levels (IU/ML)	the curative effect of antiviral therapy will be evaluated by HBsAg levels	afte treatment 48 weeks
Secondary	the change of HBeAg levels (IU/ML)	the curative effect of antiviral therapy will be evaluated by HBeAg levels	afte treatment 48 weeks