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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cz Li, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01480492
First received: November 15, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose
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 Intervention
HBeAg Positive Chronic Hepatitis B Infection Drug: Telbivudine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study the Effect of Nucleoside on Host Immune in Patients With CHB

Resource links provided by NLM:


Further study details as provided by Cz Li, Changhai Hospital:

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

Enrollment: 56
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: therapy Drug: Telbivudine
600mg,1/d,one year

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480492

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cz Li, professor, Changhai Hospital
ClinicalTrials.gov 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 )
Study First Received: November 15, 2011
Last Updated: November 28, 2011

Keywords provided by Cz Li, Changhai Hospital:
HBV
Immune
antiviral therapy

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

ClinicalTrials.gov processed this record on August 17, 2017