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

This study has been completed.
Information provided by (Responsible Party):
Cz Li, Changhai Hospital
ClinicalTrials.gov Identifier:
First received: November 15, 2011
Last updated: November 28, 2011
Last verified: November 2011
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: 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decline of hepatitis B e antigen (HBeAg) level [ Time Frame: base line-4weeks-12weeks-24weeks-end of therapy ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
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
  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

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

No publications provided by Changhai Hospital

Additional 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  30972600 
Study First Received: November 15, 2011
Last Updated: November 28, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Changhai Hospital:
antiviral therapy

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases

ClinicalTrials.gov processed this record on February 11, 2016