Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087646
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2004-07-12
Brief Title:
REPEAT Study - A Study of PEGASYS Peginterferon Alfa-2a 40KD Therapy in Combination With COPEGUS Ribavirin in Patients With Chronic Hepatitis C CHC Who Did Not Respond to Previous PegIntron Peginterferon Alfa-2b 12KDRibavirin Combination Therapy
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous PegintronRibavirin Combination Therapy
Status:
COMPLETED
Status Verified Date:
2015-12
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 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b 12KDribavirin combination therapy In these patients the effects of lengthening the duration of treatment as well as including an initial 12-week period of high-dose PEGASYS 360 micrograms sc are compared with the standard combination therapy of PEGASYS 180 micrograms sc and ribavirin 1000-1200mg po The anticipated time on study treatment is 1-2 years and the target sample size is 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