Ignite Creation Date:
2024-05-05 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00624325
Status:
COMPLETED
Last Update Posted:
2011-03-11
First Post:
2008-01-07
Brief Title:
Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
Status:
COMPLETED
Status Verified Date:
2011-03
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:
SCIN-C
Brief Summary:
For chronic hepatitis C patients unresponsive to previous PEG-IFNRBV combination therapy we propose continuous subcutaneous administration of high-dose IFN-a2b Intron A for 48 weeks in combination with 15 mgkgday RBV Rebetol and optimal management of side effects in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks We expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared to thrice weekly or daily subcutaneous injection of IFN-a2b and increased antiviral activity and biologic potency due to sustained and higher levels of a fully potent interferon protein
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| eudract 2006-000592-15 | None | None | None |