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: 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

  Eligibility

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

No publications provided

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:
HBV
Immune
antiviral therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014