Trial information
PHOENIX study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
Status: No longer recruiting
Protocol number: ML18124
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of prophylactic administration of PEGASYS plus ribavirin after liver transplantation on hepatitis C recurrence in patients with hepatitis C
Brief summary: This 2 arm study will 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 is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 115.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Percentage of patients with histological evidence of hepatitis C recurrence Time frame: 24 months post-randomization
Key secondary outcomes: 1. Non-detectable serum HCV-RNA, and evaluation of ALT levels. Time frame: After 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2004
Trial registration date: 08/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Phoenix, AZ
- Los Angeles, CA
- San Francisco, CA
- Aurora, CO
- Gainesville, FL
- Jacksonville, FL
- Chicago, IL
- Baltimore, MD
- Minneapolis, MN
- Rochester, MN
- St Louis, MO
- Omaha, NE
- New York, NY
- Cincinnati, OH
- Philadelphia, PA
- Nashville, TN
- San Antonio, TX
