The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of fibrosis progression in adult subjects with moderate to severe liver fibrosis secondary to chronic hepatitis, who failed PEG-Intron plus Rebetol treatment in protocol P02370.

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

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

Criteria

Inclusion Criteria:

• Age at entry in study P02370 18-65 years;
• Nonresponder to PEG-Intron plus Rebetol in study P02370

Exclusion Criteria:

• Patients who did not participate in the P02370 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; 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 Medical Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Iowa
      VA Medical Center Iowa City, Iowa City,  Iowa,  52246,  United States; Recruiting
      University of Iowa, Iowa City,  Iowa,  52242,  United States; Recruiting
Kentucky
      University of Louisville, HSC, Louisville,  Kentucky,  40202,  United States; Recruiting
Louisiana
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
      Louisiana State Univesity, New Orleans,  Louisiana,  70115,  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, St. Paul,  Minnesota,  55443,  United States; Recruiting
Missouri
      University of Missouri Hospital, Columbia,  Missouri,  65212,  United States; Recruiting
New York
      450 E. 69th Street, New York City,  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
      University of Cincinnati, Cincinnati,  Ohio,  45267,  United States; Recruiting
      MetroHealth Medical Center, Cleveland,  Ohio,  44109-1998,  United States; Recruiting
Pennsylvania
      Penn State University Milton S. Hershey 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; Recruiting
Argentina
      Sanatorio Municipal Julio A. Mendez, Buenos Aires,  Argentina; Recruiting
      Hospital Italiano Sociedad Italiana de Beenficencia en Buenos Aires, Buenos Aires,  Argentina; Recruiting
      Hospital F J Muniz, Buenos Aires,  Argentina; Recruiting
      Hospital Interzonal General de Agudos, La Plata,  Argentina; Recruiting
      Hospital Provinical del Centenario, Rosario,  Argentina; Recruiting
      Hospital Municipal de Gastroenterologia, Buenos Aires,  Argentina; Recruiting
      Hospital Britanico, Buenos Aires,  1280,  Argentina; Recruiting
      Hospital Universitario Austral, Pilar,  P1629AH,  Argentina; Recruiting
Australia
      Alfred Hospital, Melbourne,  Australia; Recruiting
      Sir Charles Gairdner Hospital, Nedlands,  Australia; Recruiting
      Fremantle Hospital, Fremantle,  Australia; Recruiting
      Westmead Hosptial, Sydney,  Australia; Recruiting
      Royal Perth Hospital, Perth,  6847,  Australia; Not yet recruiting
      Princess Alexandra Hospital, Brisbane,  4102,  Australia; Recruiting
      Royal Brisbane Hospital, Herston, Brisbane,  4029,  Australia; Recruiting
      Monash Medical Centre, Clayton, Melbourne,  3168,  Australia; Recruiting
      Concord Hospital, Sydney,  2137,  Australia; Recruiting
Austria
      Elisabethinen Hospital Linz, Linz,  Austria; Recruiting
      Lainz Hospital of Vienna, Vienna,  Austria; Recruiting
Belgium
      Hospital Saint LUC-UCL, BRUXELLES,  Belgium; Recruiting
      CHU De Liege, LIEGE,  Belgium; Recruiting
      Universitair ziekenhuis Gent, Gent,  9000,  Belgium; Recruiting
Brazil
      Instituto de Infectologia Emilio Ribas, Sao Paulo,  Brazil; Recruiting
      Hospital das Clinicas DAFMUSP, Sao Paolo,  Brazil; Recruiting
      Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre,  Brazil; Recruiting
      Hospital Universitario Edgard Santos, Salvador,  Brazil; Recruiting
      Hospital Amaral Carvalho, Jau,  Brazil; Recruiting
      Hospital de Clinicas da UFPR, Curitiba,  Brazil; Recruiting
      Hospital Universitario Gaffree & Guinle, Rio de Janeiro - RJ,  Brazil; Recruiting
      Hospital Sao Rafael, Salvador,  Brazil; Recruiting
      Hospital das Clinicas da FMUSP, Sao Paulo,  Brazil; Recruiting
      Hospital Universitario Clementino Fraga Filho, Rio de Janeiro,  21941-590,  Brazil; Recruiting
      Hospital Sao Paulo, Sao Paulo,  04023-900,  Brazil; Recruiting
      Hospital Das Clinicas Da Unicamp, Campinas,  13083-970,  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
      Vancouver General Hospital, Vancouver,  Canada; Recruiting
      University Health Network, Toronto,  Canada; Recruiting
      Suite #215, Edmonton,  Canada; Recruiting
      John Buhler Research Centre, Winnipeg,  Canada; Recruiting
      Heritage Medical Research Clinic, Calgary,  Canada; Recruiting
      Jewish General Hospital, Montreal,  Canada; Recruiting
      Mount Sinai Hospital, Toronto,  Canada; Recruiting
      London Health Sciences Center, London,  Canada; Recruiting
      Burrard Medical Building, Vancouver,  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
      A.P.H. Paris, Hopital Pitie-Salpetriere, Paris Cedex 13,  France; Recruiting
      A.P.H. Paris, Hopital Beaujon, Clichy,  92110,  France; Recruiting
      Hospices Civils De Lyon, Lyon Cedex 2,  France; Recruiting
      C.H.U. de Toulouse, Hopital de Purpan, Toulouse,  31059,  France; Recruiting
      CHU de Nancy, Hopital de Brabois Adultes, Vandoeuvre,  France; Recruiting
      Hopital de L'Archet 2, Nice,  France; Recruiting
      CHR d'Orleans, Hopital de la Source, Orleans,  France; Recruiting
      APH Paris, Hopital Saint Antoine, Paris,  France; Recruiting
      Hopital Saint Joseph, Marseille,  France; Recruiting
Germany
      MNR-Klinik, Gastroenterologie, Duesseldorf,  Germany; Recruiting
      Klinik fur Allgemeine und Innere Medizin der Universitat Schleswig-Holstein, Kiel,  Germany; Recruiting
      St. Josef Hosiptal Oberhausen, Oberhausen,  Germany; Recruiting
      Rheinsche Friedrich-Wilhelms-Universitaet Bonn, Bonn,  Germany; Recruiting
      Universitaetsklinikum Charite, Berlin,  Germany; Recruiting
      Medizinische Hochschule Hannover, Hannover,  Germany; Recruiting
      Universitaetskliniken des Saarlandes - Innere Med., HOMBURG / SAAR,  Germany; Recruiting
      Universitatsklinik St. Josef-Hospital, Medizinische, Bochum,  44791,  Germany; Recruiting
      Klinikum Grosshadern / LMU /Med.Klinik + Poliklinik, Munich,  81377,  Germany; Recruiting
Greece
      Hippokration Genreal Hospital of Athens, Athens,  Greece; Recruiting
      Pepagni Hospital, Heraklion,  Greece; No longer recruiting
Italy
      Azienda Osepdaliera Careggi, Firenze,  Italy; Recruiting
      Osepedale Maggiore, Milano,  Italy; Recruiting
      Ospedale San Paolo, Milano,  Italy; Recruiting
      Ospedale Molinette, Torino,  Italy; Recruiting
      Policlinico Universitario di Padova, Padova,  35128,  Italy; Recruiting
      Policlinico P. Giaccone, Palermo,  Italy; Recruiting
Mexico
      CIF Biotech/Hospital Medica Sur, Mexico,  Mexico; Recruiting
      Instituto Nacional De Ciencias Medicas Y Nutricion, Mexico,  14000,  Mexico; Recruiting
      Centro Medico "20 De Noviembre"/Torre Hospital, Mexico, D.F.,  Mexico; Recruiting
Portugal
      Hospital da Arrabida, Vila Nova de Gaia,  Portugal; Recruiting
      Servico de Medicina III, Coimbra,  Portugal; Recruiting
Puerto Rico
      Ponce Gastroenterology Research, Ponce,  Puerto Rico; Recruiting
      Unidade de Investigacion de Gastroenterologia, San Juan,  Puerto Rico; Recruiting
      VA Medical Center, San Juan,  Puerto Rico; Recruiting
Spain
      Clinica Puerta De Hierro, Madrid,  Spain; Recruiting
      Hospital Universitartio de la Princesa, Madrid,  Spain; Recruiting
      Hosptial Central de Asturias, Oviedo,  Spain; Recruiting
      Hospital Germans Trias i Pujol, Barcelona,  Spain; Recruiting
      Hospital General Universitario de Valencia, Valencia,  Spain; Recruiting
      Hosptial Clinicoo Universitario de Valencia, Valencia,  Spain; Recruiting
      Hospital Clinic i Provincial, Barcelona,  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 Hosptial, Stockholm,  Sweden; Recruiting
Switzerland
      Institut fuer Klinische Pharmakologie, Bern,  Switzerland; Recruiting
      Univerdsitaetsspital, Zurich,  Switzerland; Recruiting
Taiwan, Province of China
      National Taiwan University Hospital, Taipei,  Taiwan, Province of China; Recruiting
United Kingdom
      Freeman Hospital, Newcastle,  United Kingdom; Recruiting
      Royal Free Hospital, London,  United Kingdom; Recruiting

Study ID Numbers:  P02570
Record last reviewed:  October 2004
Record first received:  November 14, 2002
ClinicalTrials.gov Identifier:  NCT00049842
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10