Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection

Study the Effect of Nucleoside on Host Immune in Patients With CHB

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01480492

Enrollment

Registered

2011-11-29

Start date

2010-01-31

Completion date

2011-10-31

Last updated

2011-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBeAg Positive Chronic Hepatitis B Infection

Keywords

HBV, Immune, antiviral therapy

Brief summary

During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.

Interventions

DRUGTelbivudine

600mg,1/d,one year

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 66 Years

Healthy volunteers

Yes

Inclusion criteria

* 18-65 years old * chronic HBV infection * HBeAg positive,HBV DNA more than 10E5 IU/mL * ALT ≥2×UTL

Exclusion criteria

* with liver cancer * with liver failure * pregnant

Design outcomes

Primary

Measure	Time frame
change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy	base line-4 weeks-12 weeks-24 weeks-end of therapy

Secondary

Measure	Time frame
Decline of hepatitis B e antigen (HBeAg) level	base line-4weeks-12weeks-24weeks-end of therapy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026