Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422838
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2007-01-15
Brief Title:
Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
Impact of Immune Responses in Chronic Hepatitis C Genotype 123 Virus Infected Patients During Treatment With Pegylated Interferon-alpha-2b and Ribavirin CIRES
Status:
COMPLETED
Status Verified Date:
2017-01
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:
CIRES
Brief Summary:
Aim
To evaluate the effects of peginterferon and ribavirin therapy on the immune response in chronic HCV genotype 12 or 3 patients before during and after treatment
Background
Treatment of chronic hepatitis C HCV has shown a remarkable success However genotype 1 patients have reduced response rates A better understanding and improvement of these results can now be considered the greatest challenge
In chronically infected patients HCV-specific immune responses are generally weak narrowly focused and often dysfunctional The presence of HCV-specific cells suppressing the immune response regulatory T-lymphocytesTreg are able to suppress the immune response These Treg are possibly responsible for the impaired immune response
Previous studies have indicated increased Treg frequency and activity of immune regulating mechanisms locally in the liver as a result of HCV re-infection Hence these Data highlight the importance of monitoring intrahepatic immune responses in addition to peripheral immune responses Using the minimally-invasive technique of fine-needle aspiration biopsy FNAB it is now possible to obtain safe and frequent liver samples to monitor local antiviral immune responses in chronic HCV patients during antiviral therapy
Rationale and hypothesis of the study
Our previous studies and current literature support the concept that Treg may contribute to HCV persistence by suppressing HCV-spec immune responses The current study is designed to examine if peginterferon and ribavirin therapy affects the activity of Treg and DC and if this results in enhanced HCV-specific immune responses
Design
Single centre translational and observational open label study with one arm of 20 genotype 1 patients and one arm of 7 genotype 23 patients
To evaluate the effects of peginterferon and ribavirin therapy on the immune response in chronic HCV genotype 12 or 3 patients before during and after treatment
Background
Treatment of chronic hepatitis C HCV has shown a remarkable success However genotype 1 patients have reduced response rates A better understanding and improvement of these results can now be considered the greatest challenge
In chronically infected patients HCV-specific immune responses are generally weak narrowly focused and often dysfunctional The presence of HCV-specific cells suppressing the immune response regulatory T-lymphocytesTreg are able to suppress the immune response These Treg are possibly responsible for the impaired immune response
Previous studies have indicated increased Treg frequency and activity of immune regulating mechanisms locally in the liver as a result of HCV re-infection Hence these Data highlight the importance of monitoring intrahepatic immune responses in addition to peripheral immune responses Using the minimally-invasive technique of fine-needle aspiration biopsy FNAB it is now possible to obtain safe and frequent liver samples to monitor local antiviral immune responses in chronic HCV patients during antiviral therapy
Rationale and hypothesis of the study
Our previous studies and current literature support the concept that Treg may contribute to HCV persistence by suppressing HCV-spec immune responses The current study is designed to examine if peginterferon and ribavirin therapy affects the activity of Treg and DC and if this results in enhanced HCV-specific immune responses
Design
Single centre translational and observational open label study with one arm of 20 genotype 1 patients and one arm of 7 genotype 23 patients
Detailed Description:
None
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