Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275548
Status:
COMPLETED
Last Update Posted:
2011-11-11
First Post:
2006-01-10
Brief Title:
Safety and Effectiveness Using Pegasys and Copegus in Recipients of Liver Transplantation With Hepatitis C
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Prospective Randomized Multi-center Open-label Comparative Safety and Efficacy Study of Prophylactically Administered Pegylated Interferon Alfa-2aPegasys Plus Ribavirin vs No Prophylaxis Following Liver Transplantation for Hepatitis C
Status:
COMPLETED
Status Verified Date:
2011-11
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 study is being done to study the impact of prophylactic administration of antiviral therapy as compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection in liver transplant recipients
Detailed Description:
This is a multicenter prospective randomized open-label efficacy and safety study The study is being done to see whether treatment using Pegasys pegylated interferon alfa-2a and Copegus ribavirin is safer and more effective in liver transplant recipients when given before hepatitis C infection reappears or when it is given after clinical symptoms of hepatitis C reinfection appear The study is also being done in liver transplant recipients to estimate how much hepatitis C is detected over time how the body affects the study drugs the safety of the study drugs whether or not the study drugs effect the participants quality of life and whether or not the participants feel more or less depressed as a result
Participants will be put into one of two groups In the preventive group participants will receive study drugs for the treatment of recurring or returning hepatitis C before developing actual clinical symptoms The participants in the observational groups will receive study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis c infection
This study will have four parts a screening phrase a treatmentobservational phrase follow-up phase and long term safety follow-up phase Throughout all four stages of the study participants will have physical exams medical and surgical historys will be taken blood and urine tests eye exam liver biopsy chest x-ray and electrocardiogram ECG If participants are female a pregnancy test will also be performed Participants must also agree not to drink any alcoholic beverages or take any other drugs for hepatitis c infection while taking part in the study Participants must be able to return for clinic visits at scheduled intervals
Participants will be put into one of two groups In the preventive group participants will receive study drugs for the treatment of recurring or returning hepatitis C before developing actual clinical symptoms The participants in the observational groups will receive study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis c infection
This study will have four parts a screening phrase a treatmentobservational phrase follow-up phase and long term safety follow-up phase Throughout all four stages of the study participants will have physical exams medical and surgical historys will be taken blood and urine tests eye exam liver biopsy chest x-ray and electrocardiogram ECG If participants are female a pregnancy test will also be performed Participants must also agree not to drink any alcoholic beverages or take any other drugs for hepatitis c infection while taking part in the study Participants must be able to return for clinic visits at scheduled intervals
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