Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT00277758
Status:
TERMINATED
Last Update Posted:
2008-03-07
First Post:
2006-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Low Dose Interleukin 2 (IL-2) Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
A Phase I Study of Low Dose Interleukin 2 (IL-2)Monotherapy, Followed by IL-2 Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I Infection
Status:
TERMINATED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient rate of volunteer accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a treatment study trial, in which we will assess the safety and tolerability of daily dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV for 48 weeks in the treatment of chronic Hepatitis C.
Detailed Description:
This is a single center study of 12 weeks of IL-2 lead in immunotherapy followed by 48 weeks of IL2 immunotherapy in combination with Pegylated Interferon Alpha (PEG-IFN-alpha) /Ribavirin (RBV) antiviral therapy for the treatment of individuals infected with Hepatitis C virus (HCV) genotype I. The study is designed to determine whether immunotherapy immunotherapy with low dose daily IL-2 can be safely added to the standard antiviral therapy of 48 weeks of PEG-IFN and RBV. Because IL-2 targets recently antigen- activated T cells, IL-2 therapy will be initiated 12 weeks before PEG-IFN/RBV therapy, when HCV antigen load is high, to activate and expand HCV antigen-specific T cells prior to the initiation of antiviral therapy.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01AI048224 | NIH | None | https://reporter.nih.gov/quic… | View |