Studies of Immune Responses in Patients With Chronic Hepatitis B
Analysis of HBV-Specific T Cell Responses and Regulatory T Cells in Patients With Chronic Hepatitis B Virus Infection
2 other identifiers
observational
100
1 country
1
Brief Summary
Taiwan is a hyperendemic area of hepatitis B virus (HBV) infection. Previous studies demonstrated vigorous T cell responses to HBV-encoded antigens developed in patients with self-limited acute hepatitis B. In contrast, weak or no T cell responses could be detected in chronic hepatitis B (CH-B) patients. However, these immune responses are still not well known in patients with acute exacerbation (AE) of CH-B and in patients with advanced liver diseases, such as liver cirrhosis (LC) and hepatocellular carcinoma (HCC). The CD4+CD25+ regulatory T cells might suppress immune responses against foreign antigens and pathogens. The roles of CD4+CD25+ regulatory T cells in patients chronically infected with HBV remain to be clarified. The high percentage of HBV carriers in Taiwan are related to the vertical transmissions. High maternal HBV viral load may make the newborns tolerant to the HBV. However, the HBV-specific CD8+ T cells responses in the cord bloods of newborns are still unknown. Thus, we want to resolve these issues in this study. We will enroll the HBsAg (+) patients from NTUH. Blood samples will be collected. We will then analyze the HBV-specific CD8+ T cell responses and the clarify the roles of regulatory T cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedDecember 2, 2008
November 1, 2008
2.9 years
September 9, 2005
December 1, 2008
Conditions
Eligibility Criteria
You may qualify if:
- patients chronically infected with hepatitis B virus
You may not qualify if:
- coinfected with HCV or HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chien-Hung Chen, MD
National Taiwan University Hospital
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 12, 2005
Study Start
May 1, 2005
Primary Completion
April 1, 2008
Last Updated
December 2, 2008
Record last verified: 2008-11