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

This study has been completed.
Information provided by:
Hoffmann-La Roche Identifier:
First received: July 12, 2004
Last updated: December 22, 2010
Last verified: December 2010
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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: Copegus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV) [ Time Frame: 120 weeks postrandomization ] [ Designated as safety issue: No ]

    Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2.

    Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe.

    Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis.

Secondary Outcome Measures:
  • Summary of Virologic Response [ Time Frame: After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up ] [ Designated as safety issue: No ]
    Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment.

Enrollment: 115
Study Start Date: October 2004
Study Completion Date: October 2008
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
Drug: Copegus
400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks
No Intervention: 2


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00087633

  Show 28 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Disclosures Group, Hoffmann-La Roche Identifier: NCT00087633     History of Changes
Other Study ID Numbers: ML18124 
Study First Received: July 12, 2004
Results First Received: October 14, 2009
Last Updated: December 22, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 04, 2016