Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381953
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2006-09-27
Brief Title:
High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
A Comparative Study of High-dose Interferon Alfa-2a and Pegylated Interferon Alfa-2a for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
Status:
COMPLETED
Status Verified Date:
2021-08
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:
Comparison of virological breakthroughrelapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction
Detailed Description:
The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics by patients HCVRNA suppression of 360 mug peginterferon QW 9 MU interferon daily or 45 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment Comparison of virological breakthroughrelapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction
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