Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375895
Status:
TERMINATED
Last Update Posted:
2012-03-02
First Post:
2006-09-12
Brief Title:
Switch From Tacrolimus to Cyclosporin in the Treatment of Recurrent Hepatitis C After Liver Transplantation
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Prospective Open-label Single Arm Pilot Study Evaluating the Effect on Virological Response of the Switch From Tacrolimus to Cyclosporin Associated With a Peginterferon Alfa-2a Ribavirin Bitherapy in Non-responder or With Recurrent VHC Disease Liver Transplanted Patients
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In France 50 of hepatitis C virus carriers develop chronic clinical hepatitis which may lead to cirrhosis and liver transplantation Transplant infection by hepatitis C virus is constant after transplantation and recurrence causes chronic liver disease in 50 to 80 of cases The aim of this study is to assess the efficacy of cyclosporin on C virological response Patients included in the Transpeg 1 study and non-responder or with a recurrent disease will be switched from their tacrolimus therapy to cyclosporin in association with a 1 year peginterferon alfa-2a ribavirin bitherapy Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment
Detailed Description:
In France 50 of hepatitis C virus carriers develop chronic clinical hepatitis which may lead to cirrhosis and liver transplantation Transplant infection by hepatitis C virus is constant after transplantation A main factor determining the severity of recurrent hepatitis C after transplantation may be immunosuppression Thus optimization of immunosuppressive regimens might be a key aspect to improve the prognosis of chronic hepatitis C in transplanted patients The two most frequently used immunosuppressive drugs are cyclosporin and tacrolimus However it has been shown that virus replication could be inhibited by cyclosporin through the blockade of cyclophilins decreasing hepatitis C viral load and improving liver function These effects were not found with tacrolimus
The aim of our study is to assess the efficacy on C virological response of the switch from tacrolimus to cyclosporin associated with a peginterferon alfa-2a ribavirin bitherapy in non-responder or with a recurrent VHC disease liver transplanted patients
Patients will receive a 19 month cyclosporin treatment associated during 12 months with a peginterferon alfa-2a ribavirin bitherapy Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment
The aim of our study is to assess the efficacy on C virological response of the switch from tacrolimus to cyclosporin associated with a peginterferon alfa-2a ribavirin bitherapy in non-responder or with a recurrent VHC disease liver transplanted patients
Patients will receive a 19 month cyclosporin treatment associated during 12 months with a peginterferon alfa-2a ribavirin bitherapy Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIC0203058 | Other Identifier | Rennes University Hospital | None |
| LOC06-05 | OTHER | None | None |