A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT00115908
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief Summary
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 458
- Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
- Compensated liver disease
Key
- Pregnant or lactating female or males with a pregnant partner.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
- Secondary Outcome Measures
Name Time Method Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA. Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA. Undetectable HCV RNA at Week 24. End of treatment response (ETR), defined as undetectable HCV RNA at Week 48
Trial Locations
- Locations (86)
Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
🇷🇴Bucharest, Romania
Klinika infekcnich nemoci
🇨🇿Hradec Kralove, Czech Republic
Fakultni Thomayerova nemocnice
🇨🇿Prague, Czech Republic
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Slezska nemocnice
🇨🇿Opava, Czech Republic
Vseobecna fakultni nemocnice
🇨🇿Prague, Czech Republic
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Nemocnice s poliklinikou Melnik
🇨🇿Melnik, Czech Republic
Ambulance pro interni a infekcni nemoci
🇨🇿Usti nad labem, Czech Republic
Spitalul Clinic Colentina
🇷🇴Bucharest, Romania
Nuselska poliklinika - Remedis
🇨🇿Prague, Czech Republic
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
University of Orleans, Hopital de la Source
🇫🇷Orleans, France
University of Paris, Hopital Saint-Antoine
🇫🇷Paris, France
University of Paris, Hopital Pitie-Salpetriere
🇫🇷Paris, France
University of Toulouse, Clinique Dieulafoy
🇫🇷Toulouse, France
I Oddzial Dzienny SPZOZ
🇵🇱Warsaw, Poland
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
St. Vincents Hospital
🇦🇺East Melbourne, Victoria, Australia
University of Calgary
🇨🇦Calgary, Alberta, Canada
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Royal Brisbane Hospital
🇦🇺Herston, Queensland, Australia
FN Bohunice
🇨🇿Brno, Czech Republic
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
The Alfred
🇦🇺Melbourne, Victoria, Australia
University of Essen
🇩🇪Essen, Germany
Ottawa Civic Hospital
🇨🇦Ottawa, Ontario, Canada
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
University of Lyon, Hopital de l'Hotel Dieu
🇫🇷Lyon, France
B´nai-Zion Medical Center
🇮🇱Haifa, Israel
University of Duesseldorf
🇩🇪Duesseldorf, Germany
University of Frankfurt
🇩🇪Frankfurt, Germany
University of Tuebingen
🇩🇪Tuebingen, Germany
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Alberta- Liver Unit
🇨🇦Edmonton, Alberta, Canada
McMaster Clinic - Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
University of Western Ontario
🇨🇦London, Ontario, Canada
University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Katedra i Klinika Chorob Zakaznych i Hepatologii
🇵🇱Bydgoszcz, Poland
Szpital Uniwersytecki w Krakowie
🇵🇱Krakow, Poland
University of Berlin, Charite Campus Virchow Klinikum
🇩🇪Berlin, Germany
Rabin Medical Center, Beilinson Campus
🇮🇱Petah Tiqwa, Israel
University of Paris, Hopital Necker
🇫🇷Paris, France
University of Hamburg, Hospital Hamburg Eppendorf
🇩🇪Hamburg, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
University of Lille, Hopital Claude Huriez
🇫🇷Lille, France
University of Hannover
🇩🇪Hannover, Germany
University of Clichy, Hopital Beaujon
🇫🇷Clichy, France
Oddzial Chorob Watroby
🇵🇱Bialystok, Poland
Katedra i Oddzial Kliniczny Chorob Zakaznych
🇵🇱Chorzow, Poland
University of Angers, CHU Angers
🇫🇷Angers, France
University of Saarland
🇩🇪Homburg, Germany
University of Leipzig
🇩🇪Leipzig, Germany
University of Mainz
🇩🇪Mainz, Germany
Hopital de Brabois
🇫🇷Vandoeuvre, France
University of Freiburg
🇩🇪Freiburg, Germany
University of Nice, Hopital de l'Archet
🇫🇷Nice, France
University of Creteil, Hopital Henri Mondor
🇫🇷Creteil, France
University of Heidelberg
🇩🇪Heidelberg, Germany
University of Kiel
🇩🇪Kiel, Germany
Hopital Haut-Leveque
🇫🇷Pessac, France
University of Bochum, Kliniken Bergmannsheil
🇩🇪Bochum, Germany
University of Marseille, Hopital Saint Joseph
🇫🇷Marseille, France
Holy Family Hospital
🇮🇱Nazareth, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Klinika Obserwacyjno Zakazna
🇵🇱Lodz, Poland
Wojewodzki Szpital Zespolony
🇵🇱Kielce, Poland
Oddzial Zakazny
🇵🇱Poznan, Poland
Institutul de Gastroenterologie si Hepatologie
🇷🇴Iasi, Romania
Spitalul Clinic de Adulti Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Western Hospital
🇦🇺Footscray, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
University of Grenoble, Hopital Nord
🇫🇷Grenoble, France
Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
🇵🇱Warsaw, Poland
Katedra i Klinika Chorob Zakaznych
🇵🇱Wroclaw, Poland