A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
NCT ID: NCT00115908
Last Updated: 2013-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
458 participants
INTERVENTIONAL
2005-05-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Albuferon
Ribavirin
PEG-IFNalfa2a
Eligibility Criteria
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Inclusion Criteria
* Compensated liver disease
Exclusion Criteria
* A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
* A history of moderate, severe or uncontrolled psychiatric disease.
* A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.
18 Years
65 Years
ALL
No
Sponsors
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Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St. Vincents Hospital
East Melbourne, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Alberta- Liver Unit
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
McMaster Clinic - Hamilton General Hospital
Hamilton, Ontario, Canada
University of Western Ontario
London, Ontario, Canada
Ottawa Civic Hospital
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
FN Bohunice
Brno, , Czechia
Klinika infekcnich nemoci
Hradec Králové, , Czechia
Nemocnice s poliklinikou Melnik
Mělník, , Czechia
Slezska nemocnice
Opava, , Czechia
Vseobecna fakultni nemocnice
Prague, , Czechia
Nuselska poliklinika - Remedis
Prague, , Czechia
Fakultni Thomayerova nemocnice
Prague, , Czechia
Ambulance pro interni a infekcni nemoci
Ústí nad Labem, , Czechia
University of Angers, CHU Angers
Angers, , France
University of Clichy, Hopital Beaujon
Clichy, , France
University of Creteil, Hopital Henri Mondor
Créteil, , France
University of Grenoble, Hopital Nord
Grenoble, , France
University of Lille, Hopital Claude Huriez
Lille, , France
University of Lyon, Hopital de l'Hotel Dieu
Lyon, , France
University of Marseille, Hopital Saint Joseph
Marseille, , France
University of Nice, Hopital de l'Archet
Nice, , France
University of Orleans, Hopital de la Source
Orléans, , France
University of Paris, Hopital Saint-Antoine
Paris, , France
University of Paris, Hopital Pitie-Salpetriere
Paris, , France
University of Paris, Hopital Necker
Paris, , France
Hopital Haut-Leveque
Pessac, , France
University of Toulouse, Clinique Dieulafoy
Toulouse, , France
Hopital de Brabois
Vandœuvre-lès-Nancy, , France
University of Berlin, Charite Campus Virchow Klinikum
Berlin, , Germany
University of Bochum, Kliniken Bergmannsheil
Bochum, , Germany
University of Duesseldorf
Düsseldorf, , Germany
University of Essen
Essen, , Germany
University of Frankfurt
Frankfurt, , Germany
University of Freiburg
Freiburg im Breisgau, , Germany
University of Hamburg, Hospital Hamburg Eppendorf
Hamburg, , Germany
University of Hannover
Hanover, , Germany
University of Heidelberg
Heidelberg, , Germany
University of Saarland
Homburg, , Germany
University of Kiel
Kiel, , Germany
University of Leipzig
Leipzig, , Germany
University of Mainz
Mainz, , Germany
University of Tuebingen
Tübingen, , Germany
B´nai-Zion Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Organization
Jerusalem, , Israel
Holy Family Hospital
Nazareth, , Israel
Rabin Medical Center, Beilinson Campus
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Oddzial Chorob Watroby
Bialystok, , Poland
Katedra i Klinika Chorob Zakaznych i Hepatologii
Bydgoszcz, , Poland
Katedra i Oddzial Kliniczny Chorob Zakaznych
Chorzów, , Poland
Wojewodzki Szpital Zespolony
Kielce, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Klinika Obserwacyjno Zakazna
Lodz, , Poland
Oddzial Zakazny
Poznan, , Poland
Katedra i Klinika Chorob Zakaznych
Szczecin, , Poland
I Oddzial Dzienny SPZOZ
Warsaw, , Poland
Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
Warsaw, , Poland
Katedra i Klinika Chorob Zakaznych
Wroclaw, , Poland
Spitalul Clinic Colentina
Bucharest, , Romania
Institutul Clinic Fundeni
Bucharest, , Romania
Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
Bucharest, , Romania
Spitalul Clinic de Adulti Cluj-Napoca
Cluj-Napoca, , Romania
Institutul de Gastroenterologie si Hepatologie
Iași, , Romania
Countries
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References
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Neumann AU, Pianko S, Zeuzem S, Yoshida EM, Benhamou Y, Mishan M, McHutchison JG, Pulkstenis E, Mani Subramanian G. Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naive patients with genotype 1, chronic hepatitis C. J Hepatol. 2009 Jul;51(1):21-8. doi: 10.1016/j.jhep.2009.01.017. Epub 2009 Mar 11.
Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17. doi: 10.1002/hep.22403.
Other Identifiers
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ALFR-HC-04
Identifier Type: -
Identifier Source: org_study_id