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OpenTrials
Completed

NCT Number: NCT01480492

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

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.

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Key information

Conditions

HBeAg Positive Chronic Hepatitis B Infection

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telbivudine

Drug

600mg,1/d,one year

Primary outcomes

  1. change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy

    Time frame: base line-4 weeks-12 weeks-24 weeks-end of therapy

Secondary outcomes

  1. Decline of hepatitis B e antigen (HBeAg) level

    Time frame: base line-4weeks-12weeks-24weeks-end of therapy

Sponsors and collaborators

Lead sponsor

Cz Li

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 29, 2011
Registry last updated
Nov 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.