Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155155
Status:
COMPLETED
Last Update Posted:
2008-12-02
First Post:
2005-09-09
Brief Title:
Studies of Immune Responses in Patients With Chronic Hepatitis B
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Analysis of HBV-Specific T Cell Responses and Regulatory T Cells in Patients With Chronic Hepatitis B Virus Infection
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CD4CD25 regulatory T cells might suppress immune responses against foreign antigens and pathogens The roles of CD4CD25 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
Detailed Description:
The HBsAg patients from National Taiwan University Hospital will be included Screening for HLA haplotype will be performed by amplification refractory mutation system PCR method The HLA-A2 or HLA-A11 will be enrolled to the study group because these two haplotypes are the most ones in Taiwan The other HLA haplotype HBV carriers will be enrolled as HLA-mismatch control The disease spectra include inactive HBV carrier CH-B CH-B with AE defined as ALT 5 X UNL HBV-related LC HBV-related HCCs
HBsAg anti-HBs IgM anti-HBc HBeAg anti-HBe anti-HCV anti-HDV anti-HIV will be determined by commercial enzyme immunoassay kits The serum levels of HBV DNA and genotypes will be done by quantitative real-time PCR Patients who are also infected with HDV or HCV or HIV will be excluded
PBMCs will be isolated from heparinized blood samples by density gradient centrifugation on Ficoll-Hypaque The PBMC will be washed with phosphate-buffered saline PBS and resuspended in T cell medium
Analysis of HBV-specific CD8 T cell responses will be done by flow cytometry using pentamer staining
To analyze HBV-specific CD8 T cells responses in patients with chronic HBV infection prospective study This part of the study is to clarify the role of HBV-specific T cell responses during the course of acute exacerbation of CH-B Blood will be collected at four important time points
HBsAg anti-HBs IgM anti-HBc HBeAg anti-HBe anti-HCV anti-HDV anti-HIV will be determined by commercial enzyme immunoassay kits The serum levels of HBV DNA and genotypes will be done by quantitative real-time PCR Patients who are also infected with HDV or HCV or HIV will be excluded
PBMCs will be isolated from heparinized blood samples by density gradient centrifugation on Ficoll-Hypaque The PBMC will be washed with phosphate-buffered saline PBS and resuspended in T cell medium
Analysis of HBV-specific CD8 T cell responses will be done by flow cytometry using pentamer staining
To analyze HBV-specific CD8 T cells responses in patients with chronic HBV infection prospective study This part of the study is to clarify the role of HBV-specific T cell responses during the course of acute exacerbation of CH-B Blood will be collected at four important time points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NSC 94-3112-B-002-030 | None | None | None |