Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412334
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2006-12-15
Brief Title:
SYREN Study A Study of PEGASYS Peginterferon Alfa-2a 40KD Plus Copegus Ribavirin in Non-Responder Patients With Chronic Hepatitis C CHC Genotype 1
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy
Status:
COMPLETED
Status Verified Date:
2016-04
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:
This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus in patients with chronic hepatitis C CHC genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin Patients will be randomized to one of 4 groups to receive aPEGASYS 360 microgramsweek plus Copegus 1000-1200mgday bPEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mgday cPEGASYS 360microgramsweek plus Copegus 1200-1600mgday or dPEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mgday Following 48 weeks treatment there will be a 24 week period of treatment-free follow-up The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
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