Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087633
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2004-07-12
Brief Title:
PHOENIX Study - A Study of PEGASYS Peginterferon Alfa-2a 40KD and COPEGUS Ribavirin Administered After Liver Transplantation for Hepatitis C
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C
Status:
COMPLETED
Status Verified Date:
2018-02
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 2-arm study was designed to evaluate the efficacy safety and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection The anticipated time on study treatment was 3-12 months and the target sample size was 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