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PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.

NCT00087633

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Hepatitis C, Chronic

Interventions: peginterferon alfa-2a [Pegasys], Copegus

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult patients at least 18 years of age
* Positive hepatitis C virus RNA at pre-transplantation
* Primary, single-organ recipient (cadaveric donor)
* Liver transplant between 10 and 16 weeks before treatment initiation

Exclusion Criteria:

* Multi-organ or re-transplant recipient
* Evidence of current hepatitis B infection
* Seropositive for human immunodeficiency (HIV) infection

Locations (28)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
San Francisco, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Burlington, Massachusetts, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Newark, New Jersey, United States
New York, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Madison, Wisconsin, United States