Ignite Creation Date:
2024-05-06 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03210467
Status:
UNKNOWN
Last Update Posted:
2017-07-07
First Post:
2017-06-30
Brief Title:
The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral Therapy
Sponsor:
Beijing Ditan Hospital
Organization:
Beijing Ditan Hospital
Study Overview
Official Title:
The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Pegylated Interferon α-2a and EntecavirETV 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 interferonIFN α-2aPeg-IFN-α not only inhibit viral replication but also play an important role in immune regulation while entecavirETV drugs only inhibit viral replication In hepatitis B infection Plasmacytoid Dendritic CellspDCs are the main effector cells in early antiviral innate immune response This study was aimed at investigating the changes of pDCs frequency and function and the expression of costimulatory molecules CD86Cluster of Differentiation antigen 86 during Peg-IFN-αand entecavirETV therapyMeanwhile investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of pDCs function or Peg-IFN-α enhanced pDCs function which gave rise to the decline of the virus
Detailed Description:
Pegylated interferon α-2aPeg-IFN-αand entecavirETV drugs can inhibit viral replication but Peg-IFN-α also play an important role in immune regulation In hepatitis B infection Plasmacytoid Dendritic Cells pDCs are the main effector cells in early antiviral innate immune responsePeg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than entecavirETV drugs which may be related to the functional activation of pDCs in the case of hepatitis and the function enhancement of pDCs during Peg-IFN-α therapy This study was aimed at investigating the changes of pDCs frequency and function and the expression of costimulatory molecules CD86 during Peg-IFN-αandentecavirETV therapyMeanwhileinvestigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD86pDC function or recovery of CD86 pDC function led to the decrease of HBsAg and HBeAg Several studies demonstrated that HBsAg and HBeAg could damage pDC function and the loss of HBsAg and HBeAg led to recovery of CD86pDC 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