The Changes of Treg Cells Frequency and Function During Antiviral Therapy

Capital Medical University

Status: Unknown

Conditions: Chronic Hepatitis B Infection

Treatments: Drug: Peginterferon Alfa-2a

Study type: Interventional

Funder types: Other

Identifiers

NCT03210493

DTXY015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

experimental group

Experimental group

Description:

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.

Treatment:

Drug: Peginterferon Alfa-2a

control group

No Intervention group

Description:

patients who were untreated ever in immune-active phase took Nucleoside Analogues for maintenance treatment.