NCT00275548

Safety and Effectiveness Using Pegasys and Copegus in Recipients of Liver Transplantation With Hepatitis C

A Prospective, Randomized, Multi-center, Open-label, Comparative Safety and Efficacy Study of Prophylactically Administered Pegylated Interferon Alfa-2a(Pegasys) Plus Ribavirin vs. No Prophylaxis Following Liver Transplantation for Hepatitis C.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 treatment/observational 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 history's 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.

Conditions

• Liver Transplant
• Hepatitis C

Interventions

Type	Name	Description
DRUG	Pegasys	135-180 micrograms administered sc once weekly
DRUG	Copegus	400-1200 mg/day for 48 weeks

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-06-01
• Completion: 2009-04-01
• First posted: 2006-01-12
• Last updated: 2011-11-11

Locations

1 site across 1 country: United States