The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.

Condition	Treatment or Intervention	Phase
Chronic Hepatitis C Cirrhosis	Drug: Peginterferon alfa 2-b	Phase III

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

Criteria

Inclusion Criteria:

• Age at entry 18-65 years;
• Non-responders to previous treatment (minimum of 3 months) with an a interferon plus ribavirin;
• Liver biopsy demonstrating cirrhosis

Exclusion Criteria:

• Any other cause for liver disease other than chronic hepatitis C;
• History or presence of complications of cirrhosis;
• Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
• Diseases or conditions that could interfere with participation in the study

California
      Kaiser Permanente, Sacramento,  California,  95825,  United States; Recruiting
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
      Scripps Clinic, La Jolla,  California,  92037,  United States; No longer recruiting
Florida
      University of Miami, Miami,  Florida,  33136,  United States; Recruiting
Hawaii
      St. Francis Medical Center, Honolulu,  Hawaii,  96817,  United States; Recruiting
Illinois
      Northwestern Memorial Hospital, Chicago,  Illinois,  60611,  United States; Recruiting
Indiana
      Indiana University, 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
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
      Louisiana State University, New Orleans,  Louisiana,  70115,  United States; Recruiting
Maryland
      John Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting
Michigan
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States; Recruiting
Minnesota
      Minnesota Clinical Research Center, Plymouth,  Minnesota,  55443,  United States; Recruiting
Missouri
      University of Missouri Hospital, Columbia,  Missouri,  65212,  United States; No longer 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
      Duke University Medical School, Durham,  North Carolina,  27710,  United States; Recruiting
      Carolina Center for LIver Disease, Charlotte,  North Carolina,  28203,  United States; Recruiting
Ohio
      MetroHealth Medical Center, Cleveland,  Ohio,  44109-1998,  United States; Recruiting
      University of Cincinnati / Dr. Kenneth Sherman, Cincinnati,  Ohio,  45267,  United States; Recruiting
Pennsylvania
      Penn State Univeristy Milton Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Virginia
      Metropolitan Research, Fairfax,  Virginia,  22031,  United States; No longer recruiting
      INOVA Fairfax Hospital, Falls Church,  Virginia,  22042,  United States; No longer recruiting
Argentina
      Hosptial Italino-Sociedad Italiana de beneficencia en Buenos Aires, Buenos Aires,  Argentina; Recruiting
      Hospital F.J. Muniz, Buenos Aires,  Argentina; Recruiting
      Hospital Provincial del Centenario, Rosario,  Argentina; Recruiting
      Hospital Municipal de Gastroenterologia, Buenos Aires,  Argentina; Recruiting
      Hosptial Interzonal General de Agudos, La Plata,  Argentina; Recruiting
      Sanatorio Municipal Julio a. Mendez (Imos), Buenos Aires,  Argentina; Recruiting
      Hospital Britanico, Buenos Aires,  1280,  Argentina; Recruiting
      Hospital Universitario Austral, Pilar,  P1629AH,  Argentina; Recruiting
Australia
      Westmead Hospital, Sydney,  Australia; Recruiting
      Alfred Hosptial, Melbourne,  Australia; Recruiting
      Royal Perth Hospital, Perth,  6847,  Australia; Recruiting
      Princess Alexandra Hospital, Brisbane,  4102,  Australia; Recruiting
      Sir Charles Gairdner Hospital, Nedlands,  6009,  Australia; Recruiting
      Royal Brisbane Hospital, Herston, Brisbane,  4029,  Australia; Recruiting
      Fremantle Hospital, Fremantle,  6160,  Australia; Recruiting
      Monash Medical Centre, Clayton, Melbourne,  3168,  Australia; Recruiting
      Concord Hospital, Sydney,  Australia; Recruiting
      John Hunter Hospital, New Castle,  Australia; Recruiting
Austria
      Elisabethinen Hospital Linz, Linz,  Austria; Recruiting
      Lainz Hospital of Vienna, Vienna,  Austria; Recruiting
Belgium
      Hopital Saint Luc, BRUXELLES,  Belgium; Recruiting
      CHU de Liege, LIEGE,  Belgium; No longer recruiting
      Universitair ziekenhuis Gent, Gent,  9000,  Belgium; Recruiting
Brazil
      Irmandade da Santa Casa de Misericorida d Porto Alegre, Porto Alegre,  Brazil; Recruiting
      Hospital Amaral Carvalho, Jau,  Brazil; Recruiting
      Instituto de Infectolgoio emilio Ribas, Sao Paulo,  Brazil; Recruiting
      Hospital Universitario Edgard Santos, Salvadore,  Brazil; Recruiting
      Hospital Universitario Gaffree & Guinle, Rio de Janeiro - RJ,  Brazil; Recruiting
      Hospital das Clinicas da FMUSP, Sao Paulo,  Brazil; Recruiting
      Hospital de Clinicas da UFPR, Curitiba,  Brazil; Recruiting
      Hospital Universitario Clementino Fraga Filho, Rio de Janeiro,  21941-590,  Brazil; Recruiting
      Hospital Sao Paulo - Universidade Federal Sao Paulo, Sao Paulo,  04024-002,  Brazil; Recruiting
      Hospital Das Clinicas Da Unicamp, Campinas - SP,  13083-970,  Brazil; Recruiting
      Hospital Sao Rafael, Salvador - BA,  41256-900,  Brazil; Recruiting
      Hospital Das Clinicas Da Universidade Federal De Go, Goiania - GO,  74605-050,  Brazil; Recruiting
      Hospital das Clinicas da UFMG, Belo Horizonte,  30130-100,  Brazil; Recruiting
Canada
      John Buhler Research Centre, Winnipeg,  Canada; Recruiting
      Heritage Medical Research Clinic/Univeristy of Calgary, Calgary,  Canada; Recruiting
      Mount Sinai Hospital, Toronto,  Canada; Recruiting
      London Health Sciences Center, London,  Canada; Recruiting
      Vancouver General Hosptial, Vancouver,  Canada; Recruiting
      University Health Network, Toronto,  Canada; Recruiting
      Suite #215, Edmonton,  Canada; Recruiting
      Burrard Medical Building, Vancouver,  Canada; Recruiting
      Jewish General Hospital, Montreal,  H3T 1E2,  Canada; Recruiting
      Queen Elizabeth II Health Sciences Center, Halifax,  B3H 2Y9,  Canada; Recruiting
      The Toronto General Hospital - University Health Ne, Toronto,  M5G 2C4,  Canada; Recruiting
Colombia
      Fundacion Cardioinfantil, Bogota,  Colombia; Recruiting
France
      Hospices Civils de Lyon, Hotel Dieu, Lyon,  France; Recruiting
      C.H.U. de Nancy, Hopital de Brabois Adultes, Vandoeuvre-les-Nancy,  France; Recruiting
      C.H.U de Toulouse, Hoptial de Purpan, Toulouse,  France; Recruiting
      A.P.H., Paris Hoptial Saint Antoine, Paris,  France; No longer recruiting
      Hopital de L'ARchet 2, Nice,  France; Recruiting
      APH Paris, Hopital Pitie Salpetriere, Paris,  France; Recruiting
      CHR d'Orleans, Hopital de la Source, 45100 Orleans,  France; Recruiting
      Hopital Saint Joseph, Marseille,  France; Recruiting
      A.P.H. Paris, Hopital Beaujon, 92110 Clichy,  92118,  France; Recruiting
Germany
      St. Josef-Hospital Oberhausen, Oberhausen,  Germany; Recruiting
      Klinik fur Allgemeine und Innere Medizin der Universitat Schleswig-Holstein, Kiel,  Germany; Recruiting
      Universitaetsklinikum Charite, Berlin,  Germany; Recruiting
      Medizinische Hochschule Hannover, Hannover,  Germany; Recruiting
      MNR-Klinik, Gastoenterologie, Duesseldorf,  Germany; Recruiting
      Universitatsklinik St. Jesef-Hosptial, Bochum,  Germany; Recruiting
      Klinikum Grosshadern, Munich,  Germany; Recruiting
      Rheinische Freidrich-Wilhelms-Universitaet Bonn, Bonn,  Germany; Recruiting
      Universitaetskliniken des Saarlandes, Hamburg,  Germany; Recruiting
      Universitaetskrankenhaus Hamburg, Hamburg,  20246,  Germany; Recruiting
Greece
      Pepagni Hosptial, Heraklion,  Greece; No longer recruiting
      Hippokration genral Hositpal of Athens, Athens,  Greece; Recruiting
Italy
      Policlinico Universitario di Padova, Padova,  Italy; Recruiting
      Azienda Ospedaliera Careggi, Firenze,  Italy; Recruiting
      D.I.M.I Universita Di Genova, Genova,  Italy; Recruiting
      Policlinico Giaccone, Palermo,  Italy; Recruiting
      Policlinico Uniersitario di Modena, Modena,  Italy; Recruiting
      Ospedale Molinette, Torino,  Italy; Recruiting
      Ospedale Maggiore, Milano,  Italy; Recruiting
      Ospedale San Paolo, Milano,  Italy; Recruiting
      Policlinico S.Orsola-Malpighi, Bologna,  40138,  Italy; Recruiting
Mexico
      Centro Medico "20 de Noviembre" Torre Hospital, Mexico City,  Mexico; Recruiting
      Instituto Nacional De Ciencias Medicas Y Nutricion, Mexico,  14000,  Mexico; Recruiting
      CIF BIOTEC/Hospital Medica Sur, Mexico, D.F.,  14050,  Mexico; Recruiting
Norway
      Aker University Hospital, Oslo,  0514,  Norway; Recruiting
Portugal
      Servico de Medicina III-HUC, Coimbra,  Portugal; Recruiting
      Hospital da Arrabida, V.N. de Gaia,  4400,  Portugal; Recruiting
Puerto Rico
      Ponce Gasstroenterology Research, Ponce,  Puerto Rico; Recruiting
      VA Medical Center, San Juan,  00927-5800,  Puerto Rico; Recruiting
      Unidad de Investigacion de Gastroenterologia, San Juan,  00935,  Puerto Rico; Recruiting
Spain
      Hospital Universitario de la Princesa, Madrid,  Spain; Recruiting
      Hospital Clinic I Provincial, Barcelona,  Spain; Recruiting
      Hospital General Universitario de Valencia, Valencia,  Spain; Recruiting
      Hospital General Universitario de Valencia, Valencia,  Spain; Recruiting
      HOstpial Germans Trias i Pujol, Barcelona,  Spain; Recruiting
      Clnica Puerto de Hierro, Madrid,  Spain; Recruiting
      Hospital Central de Asturias, Oviedo,  Spain; Recruiting
      Hospital Vall D'Hebron, Barcelona,  Spain; Recruiting
      Hospital 12 de Octubre, Madrid,  28041,  Spain; Recruiting
      Hospital Universitario Virgen del Rocio, Sevilla,  41013,  Spain; Recruiting
Sweden
      Karolinska Hospital, Stockholm,  Sweden; Recruiting
Switzerland
      Universitaetsspital Zuerich, Zurich,  Switzerland; Recruiting
      Institut fuer Klinishcer Pharmakologie, Bern,  Switzerland; Recruiting
Taiwan, Province of China
      National Taiwan University Hospital, Taipei,  Taiwan, Province of China; Recruiting
United Kingdom
      Royal Free Hospital, London,  United Kingdom; Recruiting
      Freeman Hospital, Newcastle,  United Kingdom; Recruiting
      Southampton General Hospital, Southampton,  SO166YD,  United Kingdom; Recruiting

Study ID Numbers:  P02569
Record last reviewed:  March 2005
Last Updated:  March 8, 2005
Record first received:  November 6, 2002
ClinicalTrials.gov Identifier:  NCT00048724
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08