Ignite Creation Date:
2024-05-05 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00574652
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2007-12-14
Brief Title:
Evaluation of Clinical Efficacy and Immunologic Response After IL-2 Therapy in HCV-related Vasculitis Patients
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
ANRS HC 21 VASCU IL-2 Evaluation of the Cellular Immune Response Clinical Efficacy and Tolerance After IL-2 Therapy in HCV-related Vasculitis Patients Resistant to Conventional Therapy
Status:
COMPLETED
Status Verified Date:
2008-01
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:
None
Brief Summary:
A systemic Vasculitis is found in 5 to 10 of HCV infected patients with mixed cryoglobulinemia MC It mainly involves the skin peripheral nerve and the kidney and may be life threatening Twenty to 30 of HCV-MC Vasculitis patients are resistant to conventional therapy ie antiviral therapy andor immunosuppressors and still have an active disease Thus new therapeutic approaches are necessary in such patients We recently described a regulatory T cell Treg deficiency in HCV-related Vasculitis patients Immunomodulatory effects of interleukin-2 IL-2 are well established notably the preferential expansion of Treg able to suppress inflammatory responses mediated by CD4 and CD8 T cells
Detailed Description:
A systemic Vasculitis is found in 5 to 10 of HCV infected patients with mixed cryoglobulinemia MC It mainly involves the skin peripheral nerve and the kidney and may be life threatening 15 of death Twenty to 30 of HCV-MC Vasculitis patients are resistant to conventional therapy ie antiviral therapy andor immunosuppressors and still have an active disease An antiviral therapy with Peg-interféron is generally prescribed to control Vasculitis lesions and to slow down the hepatic fibrosis progression Thus new therapeutic approaches are necessary in such patients We recently described a CD4 CD25 regulatory T cell Treg deficiency in HCV-related Vasculitis patients Immunomodulatory effects of interleukin-2 IL-2 are well established notably the preferential expansion of Treg able to suppress inflammatory responses mediated by CD4 and CD8 T cells
Objective To evaluate the cellular immune response after IL-2 therapy in HCV-MC Vasculitis patients resistant to conventional therapy
Methods This is an open prospective phase III trial Four cycle of subcutaneous IL-2 therapy 3 millions IUday from day 1 to 5 every 21 days will be carried out at W1 W3 W6 and W9 The first cure will be carried out with half-dose of IL-2 15 millions IUday in the hospital If the tolerance is satisfactory the later cures will be done ambulatory All patients will be followed after IL-2 therapy S11 to S37
End points
1 Clinical tolerance Absence of Vasculitis flare during and after IL-2 therapy
2 Immunologic follow-up of Treg and of HCV cellular immune response before during and after IL-2 therapy
3 Clinical efficacy follow-up of clinical manifestations of HCV-MC Vasculitis during and after IL-2 therapy
Schedule Duration of patients inclusion period is estimated 18 months Duration of therapy and follow-up is estimated 9 months Analysis of data will last 7 months Overall duration 34 months
Objective To evaluate the cellular immune response after IL-2 therapy in HCV-MC Vasculitis patients resistant to conventional therapy
Methods This is an open prospective phase III trial Four cycle of subcutaneous IL-2 therapy 3 millions IUday from day 1 to 5 every 21 days will be carried out at W1 W3 W6 and W9 The first cure will be carried out with half-dose of IL-2 15 millions IUday in the hospital If the tolerance is satisfactory the later cures will be done ambulatory All patients will be followed after IL-2 therapy S11 to S37
End points
1 Clinical tolerance Absence of Vasculitis flare during and after IL-2 therapy
2 Immunologic follow-up of Treg and of HCV cellular immune response before during and after IL-2 therapy
3 Clinical efficacy follow-up of clinical manifestations of HCV-MC Vasculitis during and after IL-2 therapy
Schedule Duration of patients inclusion period is estimated 18 months Duration of therapy and follow-up is estimated 9 months Analysis of data will last 7 months Overall duration 34 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRS HC 21 Vascu-IL2 | None | None | None |