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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01480492
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : November 29, 2011
Information provided by (Responsible Party):
Cz Li, Changhai Hospital

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.

Condition or disease Intervention/treatment Phase
HBeAg Positive Chronic Hepatitis B Infection Drug: Telbivudine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study the Effect of Nucleoside on Host Immune in Patients With CHB
Study Start Date : January 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine

Arm Intervention/treatment
No Intervention: therapy Drug: Telbivudine
600mg,1/d,one year

Primary Outcome Measures :
  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 Outcome Measures :
  1. Decline of hepatitis B e antigen (HBeAg) level [ Time Frame: base line-4weeks-12weeks-24weeks-end of therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01480492

China, Shanghai
Changhai Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Cz Li
Study Director: Wan Mo Bin, Professor Changhai Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cz Li, professor, Changhai Hospital Identifier: NCT01480492     History of Changes
Other Study ID Numbers: HBV20111115
09zr400500 ( Other Grant/Funding Number: Shanghai Natural Science Fund )
30972600 ( Other Grant/Funding Number: National Natural Science Foundation of China )
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: November 29, 2011
Last Verified: November 2011

Keywords provided by Cz Li, Changhai Hospital:
antiviral therapy

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action