Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2004

Trial Registration Date: 08/26/2005

Date Last Updated: 08/15/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 2:12:36 PM