Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03209011
Status:
UNKNOWN
Last Update Posted:
2017-07-12
First Post:
2017-06-30
Brief Title:
The Changes of CD4T Cells Frequency and Function During Antiviral Therapy
Sponsor:
Yao Xie
Organization:
Beijing Ditan Hospital
Study Overview
Official Title:
The Changes of CD4T Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
RECRUITING
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:
Pegylated interferon α-2aPeg-IFN-α not only inhibit viral replication but also play an important role in immune regulation while Nucleoside analogue drugs only inhibit viral replication In hepatitis B infection CD4T Cells are the main effector cells in adaptive immune response This study was aimed at investigating the changes of CD4T Cells frequency and function and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analogue therapyMeanwhile the investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of CD4T Cells function or Peg IFN - alpha enhanced CD4T Cells function which gave rise to the decline of the virus
Detailed Description:
Pegylated interferon α-2aPeg-IFN-αand Nucleoside analogue drugs can inhibit viral replication but Peg-IFN-α also play an important role in immune regulation In hepatitis B infection CD4T Cells are the main effector cells in adaptive immune responsePeg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analogue drugs which may be related to the functional activation of CD4T Cells in the case of hepatitis and the function enhancement of CD4T Cells during Peg-IFN-α therapy This study was aimed at investigating the changes of CD4T Cells frequency and function and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analogue therapyMeanwhile the investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD4T cells function or recovery of CD4T Cells function led to the decrease of HBsAg and HBeAg Several studies demonstrated that HBsAg and HBeAg could damage CD4T cells function and the loss of HBsAg and HBeAg led to recovery of CD4T cells function
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