Viewing Study NCT03209037



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Last Modification Date: 2024-10-26 @ 12:27 PM
Study NCT ID: NCT03209037
Status: UNKNOWN
Last Update Posted: 2017-07-12
First Post: 2017-06-30

Brief Title: The Changes of CD8T Cells Frequency and Function During Antiviral Therapy
Sponsor: Beijing Ditan Hospital
Organization: Beijing Ditan Hospital

Study Overview

Official Title: The Changes of CD8T 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 CD8T cells are the main effector cells in adaptive immune response This study was aimed at investigating the changes of CD8T 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-α suppressed the virus and the reduction of virus led to the recovery of CD8T cells function or Peg IFN - alpha enhanced CD8T 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 CD8T 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 CD8T cells in the case of hepatitis and the function enhancement of CD8T cells during Peg-IFN-α therapy This study was aimed at investigating the changes of CD8T 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 CD8T cells function or recovery of CD8T cells function led to the decrease of HBsAg and HBeAg Several studies demonstrated that HBsAg and HBeAg could damage CD8T cells function and the loss of HBsAg and HBeAg led to recovery of CD8T 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