The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an a interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus Rebetol will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-intron therapy monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Condition	Treatment or Intervention	Phase
Chronic Hepatitis C Liver Fibrosis Cirrhosis	Drug: Peginterferon alfa-2B  Drug: Ribavirin	Phase III

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age at entry 18-65
• Positive for Hepatitis C
• Nonresponder to previous treatment (minimum of 3 months) with an a-Interferon plus ribavirin
• Liver Biopsy demonstrating moderate to severe fibrosis or cirrhosis

Exclusion Criteria:

• Any cause for the liver disease other than chronic hepatitis C
• History or presence of complications of cirrhosis
• Alcohol or illicit drug use or methadone treatment within the past 2 years
• Treatment for chronic hepatitis C within the previous 6 months
• Diseases or conditions that could interfere with the subject's participation in and completion of the study

California
      Kaiser Permanente, Sacramento,  California,  95825,  United States; Recruiting
      Scripps Clinic, LaJolla,  California,  92037,  United States; No longer recruiting
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
Florida
      University of Miami, Miami,  Florida,  33136,  United States; Recruiting
Hawaii
      St. Francis Medical Center, Honolulu,  Hawaii,  96817,  United States; Recruiting
Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Indiana
      Indiana Univeersity, Indianapolis,  Indiana,  46202,  United States; Recruiting
Iowa
      University of Iowa, Iowa City,  Iowa,  52242,  United States; Recruiting
      VA Medical Center Iowa City, Iowa City,  Iowa,  52246,  United States; Recruiting
Kentucky
      University of Louisville, Louisville,  Kentucky,  40202,  United States; Recruiting
Louisiana
      Louisiana State University, New Orleans,  Louisiana,  70115,  United States; Recruiting
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting
Michigan
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States; Recruiting
Minnesota
      Minnesota Clinical Research Center, St. Paul,  Minnesota,  55443,  United States; Recruiting
Missouri
      University of Missouri Hopsital, Columbia,  Missouri,  65212,  United States; Recruiting
New York
      450 E. 69th Street, New York,  New York,  10021,  United States; Recruiting
      Beth Israel Medical Center, New York,  New York,  10003,  United States; Recruiting
North Carolina
      Carolina Center for Liver Disease, Charlotte,  North Carolina,  28203,  United States; Recruiting
      Duke University Medical School, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      University of Cincinnati, Cincinnati,  Ohio,  45267,  United States; Recruiting
      MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States; Recruiting
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Completed
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
      University of Pittsburg, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Virginia
      Metroplitan Research, Fairfax,  Virginia,  22031,  United States; Recruiting
      Inova Fairfax Hopsital, Falls Church,  Virginia,  22042,  United States; No longer recruiting
Argentina
      Hospital Provicial Del Centenario, Rosario,  Argentina; Recruiting
      Hospital Italiano-Sociedad Italiana De Beneficenci, Buenos Aires,  Argentina; Recruiting
      Hospital F.J. Muniz, Buenos Aires,  Argentina; Recruiting
      Hospital Britanico, Buenos Aires,  Argentina; Recruiting
      Sanatorio Municipal Julio A. Mendez (IMOS), Buenos Aires,  Argentina; Recruiting
      Udaondo Hospital Municipal de Gastroenterologie, Buenos Aires,  Argentina; Recruiting
      Hopsital Universitario Austral, Pilar,  Argentina; Recruiting
      Dr. Rodolfo Rossi, La Plata,  Argentina; Recruiting
Australia
      Fremantle Hospital, Fremantle,  Australia; Recruiting
      Sir Charles Gairdner Hospital, Nedlands,  Australia; Recruiting
      Monash Medical Centre, Melbourne,  Australia; Recruiting
      Royal Perth Hospital, Perth,  Australia; Recruiting
      Royal Brisbane Hospital, Brisbane,  Australia; Recruiting
      Princess Alexandra Hospital, Brisbane,  Australia; Recruiting
      Concord Hospital, Sydney,  Australia; Recruiting
      John Hunter Hospital, Newcastle,  Australia; Recruiting
Australia, New South Wales
      Westmead Hospital, Westmead,  New South Wales,  Australia; Recruiting
Australia, Victoria
      Alfred Hospital, Melbourne,  Victoria,  Australia; Recruiting
Austria
      Salzburg General Hospital, Salzburg,  Austria; No longer recruiting
      Lainz Hospital of Vienna, Vienna,  Austria; Recruiting
      Elisabethinen Hospital Linz, Linz,  Austria; Recruiting
Belgium
      Sint Jan, Brugge,  Belgium; No longer recruiting
      Hopital Saint Luc - UCL, BRUXELLES,  Belgium; Recruiting
      CHU de Liege, LIEGE,  Belgium; Recruiting
      Universitair ziekenhuis Gent, Gent,  Belgium; Recruiting
Brazil
      Hospital Amaral Carvalho, Jau,  Brazil; Recruiting
      Hopital Das Clinicas Dafmusp, Sao Paulo,  Brazil; Recruiting
      Irmandade da Santa Casa de Misericordia, Porto Alagre - RS,  Brazil; Recruiting
      Instituto de Infectologia Emilio Ribas, Sao Paulo,  Brazil; Recruiting
      Hospital Universitario Clementino Fraga Filho, Rio de Janeiro,  Brazil; Recruiting
      Hospital Universitario Gaffree & Guinle, Rio de Janeiro - RJ,  Brazil; Recruiting
      Hopsital Sao Rafael, Salvador - BA,  Brazil; Recruiting
      Hospital das Clinicas Dafmusp, Sao Paulo,  Brazil; Recruiting
      Hospital Sao Paolo - Universidade Federal Sao Paolo, Sao Paolo,  Brazil; Recruiting
      Hospital das Clinicas da UNICAMP, Campinas - SP,  Brazil; Recruiting
      Hospital das Clinicas da Universidade de Goias, Goiania - GO,  Brazil; Recruiting
      Hospital de Clinicas da UFPR, Curitiba,  Brazil; Recruiting
      Hospital Universitario Edgard Santos, Salvador,  Brazil; Recruiting
      Hospital das Clinicas da UFMG, Belo Horizonte,  30130-100,  Brazil; Recruiting
Canada
      Walter Mackenzie HSC - 2E1.16, Edmonton,  Canada; Recruiting
      Jewish General Hospital, Montreal,  Canada; Recruiting
      Mount Sinai Hospital, Toronto,  Canada; Recruiting
      Burrard Medical Building, Vancouver,  Canada; Recruiting
      John Buhler Research Centre, Winnipeg,  Canada; Recruiting
      Vancouver General Hospital, Vancouver,  Canada; Recruiting
      University Health Network, Toronto,  Canada; Recruiting
      London Health Sciences Center - University Campus, London,  Canada; Recruiting
      Heritage Medical Research Clinic/University of Calgary, Calgary,  Canada; Recruiting
      Queen Elizabeth II Health Sciences Center, Halifax,  Canada; Recruiting
      Centre Universitaire de Sante Mcgill, Montreal,  Canada; No longer recruiting
      The Toronto General Hospital - University Health Network, Toronto,  Canada; Recruiting
      Heritage Medical Research Clinic/University of Calg, Calgary,  T2N 4N1,  Canada; Recruiting
Colombia
      Fundacion Cardioinfantil, Bogota,  Colombia; Recruiting
France
      A.P.H. Paris, Hopital Saint Antoine, Paris cedex,  France; Recruiting
      Hopital Saint Joseph, Marseille Cedex 08,  France; Recruiting
      C.H.R. d'Orleans, Hopital de la Source, Orleans,  France; Recruiting
      C.H.U de Nancy, Hopital de Brabois Adultes, Vandouevre les Nancy,  France; Recruiting
      Hopital de l'Archet 2, Nice Cedex,  France; Recruiting
      A.P.H. Paris, Hopital Beaujon, Clichy,  France; Recruiting
      Hospices Civils de Lyon, Hotel Dieu, Lyon,  France; Recruiting
      A.P.H. Paris, Hopsital Pitie-Salpetriere, Paris,  75651,  France; Recruiting
      C.H.U. de Toulouse, Hopital de Purpan, Toulouse,  31059,  France; Recruiting
Germany
      MNR-Klinik, Gastroenterologie, Duesseldorf,  Germany; Recruiting
      Universitaetsklinik St. Josef-Hospital, Medizinische Klinik I, Bochum,  Germany; Recruiting
      Klinikum Grosshadern/LMU/Med. Klinik + Poliklinik II, Munich,  Germany; Recruiting
      Universitaetsklinikum Charite - Campus Virchow Klin, Berlin,  Germany; Recruiting
      Universitaetskliniken des Saarlandes - Innere Med., HOMBURG / SAAR,  Germany; Recruiting
      Medizinische Hochschule Hannover, Hannover,  Germany; Recruiting
      Rheinische Friedrich-Wilhelms-Universitaet Bonn, Bonn,  Germany; Recruiting
      Klinik fur Allgemeine und Innere Medizin der Universitat Schleswig-Holstein, Kiel,  Germany; Recruiting
      St. Josef-Hospital Oberhausen, Oberhausen,  Germany; Recruiting
      Universitaet Hamburg/Gastroenterologie/UKE-Med.Univ, Hamburg,  Germany; Recruiting
Greece
      Pepagni Hospital, Heraklion,  Greece; No longer recruiting
      Hippokration General Hospital of Athens, Athens,  Greece; Recruiting
Italy
      Ospedale Maggiore-IRCCS Policlinico, Milan,  Italy; Recruiting
      Policlinico Universitario di Modena, Modena,  Italy; Recruiting
      D.I.M.I Universita Di Genova, Genova,  Italy; Recruiting
      Policlinico Unversitario di Padova, Padova,  Italy; Recruiting
      Polilinico P. Giaccone, Palermo,  Italy; Recruiting
      Ospedale San Paolo, Milano,  Italy; Recruiting
      Ospedale Molinette, Torino,  10126,  Italy; Recruiting
      Policlinico S. Orsola-Malpighi, Bologna,  Italy; Recruiting
      Azienda Ospedaliera Careggi, Firenze,  Italy; Recruiting
Mexico
      Instituto Nacional De Ciencias Medicas Y Nutricion, Mexico,  Mexico; Recruiting
      CIF Biotec/Hospital Medica Sur, Mexico,  Mexico; Recruiting
      Sociedad Espanola de Beneficencia de Puebla, Puebla,  Mexico; No longer recruiting
      Centro Medico Nacional Siglo XXI I.M.S.S, Mexico, D.F.,  Mexico; No longer recruiting
      Centro Medico "20 de Noviembre"/Torre Hospital, Mexico, D.F.,  Mexico; Recruiting
Norway
      Aker Sykehus, Oslo,  Norway; No longer recruiting
Portugal
      Servico de Medicina III - Huc, Coimbra,  Portugal; Recruiting
      Hopital da Arrabida, V.N. de Gaia,  Portugal; Recruiting
Puerto Rico
      Ponce Gastroenterology Research, Ponce,  Puerto Rico; Recruiting
      Unidad de Investigacion de Gastoenterologia, San Juan,  Puerto Rico; Recruiting
      VA Medical Center, San Juan,  Puerto Rico; Recruiting
Spain
      Hospital Germans Trias i Pujol, Barcelona,  Spain; Recruiting
      Hospital Vall d'Hebron, Barcelona,  Spain; Recruiting
      Hospital clinic i Provincial, Barcelona,  Spain; Recruiting
      Clinica Puerta de Hierro, Madrid,  Spain; Recruiting
      Hopsital Clinio Universitario de Valencia, Valencia,  Spain; Recruiting
      Hopsital General Universitario de Valencia, Valencia,  Spain; Recruiting
      Hospital Universitario de la Princesa, Madrid,  Spain; Recruiting
      Hospital Universitario Virgen del Rocio, Sevilla,  Spain; Recruiting
      Hospital Central de Aaturias, Oviedo,  Spain; Recruiting
      Hospital 12 de Octubre, Madrid,  Spain; Recruiting
Sweden
      Karolinska Hospital, Stockholm,  Sweden; Recruiting
Switzerland
      Universitaetsspital Zuerich, Zuerich,  Switzerland; Recruiting
      Institut fuer klinische Pharmakologie, Bern,  Switzerland; Recruiting
Taiwan, Province of China
      National Taiwan University Hospital, Taipei,  Taiwan, Province of China; Recruiting
United Kingdom
      Freeman Hospital, Newcastle upon Tyne,  United Kingdom; Recruiting
      Royal Free Hospital, London,  United Kingdom; Recruiting
      King's College Hospital, London,  United Kingdom; No longer recruiting
      Glasgow Royal Infirmary, Glasgow,  United Kingdom; No longer recruiting
      Southhampton General Hospital, Southampton,  United Kingdom; Recruiting

Study ID Numbers:  P02370
Record last reviewed:  October 2004
Record first received:  June 13, 2002
ClinicalTrials.gov Identifier:  NCT00039871
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10