NCT03210493

The Changes of Treg Cells Frequency and Function During Antiviral Therapy

The Changes of Treg Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-07-07
• Last updated: 2017-07-12

Locations

1 site across 1 country: China