Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02282709
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2014-10-23
Brief Title:
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients
Status:
COMPLETED
Status Verified Date:
2015-10
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:
ImmunoDual
Brief Summary:
Rationale Chronic HCV infection is characterised by a weak HCV specific CD8 T cell response due to continuous pressure of high viral load Treatment of chronic HCV patients with ASV and DCV will result in a significant drop in HCV viral load At present no information is available on the immunological effects of treatment with ASV and DCV nor on the early effects of viral load reduction caused by a compound that is thought not to possess direct immunomodulatory effects This information will be crucial for a better understanding of the mechanisms that may limit the effectiveness of treatment occurrence of viral rebound or relapses during at the end of treatment or during the follow up period
Objective To evaluate in detail the functionality of immune cells in blood in chronic HCV patients before during and after treatment with ASV and DCV in an IFN-free regimen
Study design This is an investigator-initiated single center open label study with one arm of 12 patients
Study population Adult chronic HCV patients with genotype 1b who are previous non-responders to the treatment
Intervention if applicable All patients will be treated with twice daily a 200 mg oASV and once daily a 60 mg DCV for 24 weeks
Main study parametersendpoints
1 Phenotype and function of blood leukocytes during treatment frequency of HCV-specific T cells NK cells and monocytes
2 Gene expression levels of leukocyte populations before during and after treatment
3 Gene expression levels of the type I IFN signaling pathway on whole blood samples
4 Serum cytokines levels using multiplex platforms
Objective To evaluate in detail the functionality of immune cells in blood in chronic HCV patients before during and after treatment with ASV and DCV in an IFN-free regimen
Study design This is an investigator-initiated single center open label study with one arm of 12 patients
Study population Adult chronic HCV patients with genotype 1b who are previous non-responders to the treatment
Intervention if applicable All patients will be treated with twice daily a 200 mg oASV and once daily a 60 mg DCV for 24 weeks
Main study parametersendpoints
1 Phenotype and function of blood leukocytes during treatment frequency of HCV-specific T cells NK cells and monocytes
2 Gene expression levels of leukocyte populations before during and after treatment
3 Gene expression levels of the type I IFN signaling pathway on whole blood samples
4 Serum cytokines levels using multiplex platforms
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