Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466219
Status:
COMPLETED
Last Update Posted:
2007-04-27
First Post:
2007-04-25
Brief Title:
RibavirinPegasys Treatment of Recurrent Hepatitis C After Liver Transplant
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-04
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:
The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirinPEG-IFN-alpha combined treatment for 48 weeks
Detailed Description:
The aim of the study is to assess whether patients fulfilling the criteria as defined in section 3 will benefit from a treatment with ribavirinPEG-a-IFN combined treatment This study will be open to all patients with histologically documented hepatitis C recurring after LT provided that all inclusion and exclusion criteria as defined below are met and irrespectively of the pattern of response to a previous antiviral treatment if any
The benefit will be assessed in terms of biochemical normalization of serum transaminases levels virological disappearance of HCV RNA from serum and histological amelioration of the histological signs of hepatitis response The presence of a sustained virological response as defined below in section 6 will also be studied in relation to the early kinetics of serum HCV RNA in keeping with recent data obtained in chronic hepatitis C patients which suggest that an early rapid decrease of HCV viremia is associated with a durable response
The benefit will be assessed in terms of biochemical normalization of serum transaminases levels virological disappearance of HCV RNA from serum and histological amelioration of the histological signs of hepatitis response The presence of a sustained virological response as defined below in section 6 will also be studied in relation to the early kinetics of serum HCV RNA in keeping with recent data obtained in chronic hepatitis C patients which suggest that an early rapid decrease of HCV viremia is associated with a durable response
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