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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00087633
First Posted: July 14, 2004
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hoffmann-La Roche
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

    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 ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087633


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00087633     History of Changes
Other Study ID Numbers: ML18124
First Submitted: July 12, 2004
First Posted: July 14, 2004
Results First Submitted: October 14, 2009
Results First Posted: January 24, 2011
Last Update Posted: January 24, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs