Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT00402428
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief Summary
This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1331
- Diagnosis of chronic hepatitis C.
- Liver biopsy performed within 2 years of Day 0 or during screening.
- Infected with hepatitis C virus genotype 1.
- Interferon alfa treatment naïve (ie, have never been treated with an interferon product).
- Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.
- Have compensated liver disease.
Key
- Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.
- History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
- Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).
- Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.
- A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).
- Active seizure disorder within the last 2 years.
- Organ transplant other than cornea and hair transplant.
- Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).
- Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
- Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.
- Received any experimental agent within 28 days prior to Day 0.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 albumin interferon alfa-2b 1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day 3 Ribavirin 1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day 2 albumin interferon alfa-2b 900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day 1 Ribavirin 180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day 1 peginterferon alfa-2a 180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day 2 Ribavirin 900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
- Primary Outcome Measures
Name Time Method Sustained virologic response (SVR) Week 72
- Secondary Outcome Measures
Name Time Method Rapid virologic response Week 4 Early virologic response Week 12 Undetectable HCV RNA Week 24 and Week 48 Normalization of ALT (a liver enzyme) Week 48 Quality of life evaluation throughout the entire study Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing) Throughout the entire study
Trial Locations
- Locations (165)
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Maryland Digestive Disease Center
🇺🇸Laurel, Maryland, United States
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Medical University of Vienna
🇦🇹Wien, Austria
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
Klinika infekcních chorob
🇨🇿Brno, Czech Republic
Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego
🇵🇱Wrocław, Poland
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Alan D Tice, MD, LLC
🇺🇸Honolulu, Hawaii, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Liver Specialist of Texas
🇺🇸Houston, Texas, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
USC Keck School of Medicine
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
GI of Atlanta
🇺🇸Atlanta, Georgia, United States
Northwest Georgia Gastroenterology Associates
🇺🇸Marietta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Indiania University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Center for Viral Hepatits
🇺🇸Baltimore, Maryland, United States
Digestive Health Specialist
🇺🇸Tupelo, Mississippi, United States
Duke Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Hospital of University of PA
🇺🇸Philadelphia, Pennsylvania, United States
Nashville Gastroenterology
🇺🇸Nashville, Tennessee, United States
Nashville Gastrointestinal Specialists
🇺🇸Nashville, Tennessee, United States
Liver Institute at Methodist Dallas
🇺🇸Dallas, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
UT Southwesten Medical Center
🇺🇸Dallas, Texas, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
John Hunter Hospital
🇦🇺New Lambton, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
UCLA / West LA VAMC
🇺🇸Los Angeles, California, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Shands Jacksonville Medical Center
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
University California-San Diego
🇺🇸San Diego, California, United States
University Hepatitis Center
🇺🇸Sarasota, Florida, United States
University of Colorado
🇺🇸Denver, Colorado, United States
San Diego Digestive Diseases Consultants, Inc
🇺🇸San Diego, California, United States
University of Florida - Gainesville
🇺🇸Gainesville, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
New York Hospital - Cornell
🇺🇸New York, New York, United States
Faculty Practice Associates
🇺🇸New York, New York, United States
Univ.-Klinik fuer Innere Medizin
🇦🇹Innsbruck, Austria
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Western Hospital
🇦🇺Footscray, Victoria, Australia
Venture Research Institute
🇺🇸N. Miami Beach, Florida, United States
Heritage Medical Research Clinic
🇨🇦Calgary, Alberta, Canada
University of Western Ontario Hospital
🇨🇦London, Ontario, Canada
Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
Medizinische Universitätsklinik Graz
🇦🇹Graz, Austria
Royal Perth Hospital
🇦🇺Perth, Australia
University of Manitoba Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
St. Louis University
🇺🇸St Louis, Missouri, United States
INOVA Fairfax Hospital
🇺🇸Annandale, Virginia, United States
Virginia Commonwealth University Medical Ctr
🇺🇸Richmond, Virginia, United States
Va Health Care System
🇺🇸Miami, Florida, United States
Hôpital Saint-Antoine
🇫🇷Paris, France
CHU de Lyon, Hôpital de l'Hôtel Dieu
🇫🇷Lyon Cedex 02, France
Klinika Infekcních nemocí
🇨🇿Hradec Kralove, Czech Republic
Ambulance pro interni a infekcni nemoci
🇨🇿Usti nad Labem, Czech Republic
Nemocnice s poliklinikou Melník
🇨🇿Melnik, Czech Republic
Slezská nemocnice
🇨🇿Opava, Czech Republic
Vseobecna fakultní nemocnice
🇨🇿Praha 2, Czech Republic
Nuselská poliklinika
🇨🇿Praha 4, Czech Republic
Hopital de La Source
🇫🇷Orleans, France
Universitätsklinik Düsseldorf
🇩🇪Duesseldorf, Germany
CHU Purpan Clinique Dieulafoy
🇫🇷Toulouse Cedex, France
G.B.Pant Hospital
🇮🇳New Delhi, India
Rambam Health Care Campus
🇮🇱Haifa, Israel
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Holy Family Hospital
🇮🇱Nazareth, Israel
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Rabin Medical Center Beilinson Campus
🇮🇱Petach Tikva, Israel
Akademia Medyczna
🇵🇱Warszawa, Poland
Uniwersytet Medyczny
🇵🇱Łódź, Poland
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Spitalul Clinic Colentina
🇷🇴Bucharest, Romania
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
Spitalul Clinic de Adulti Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Royal London Hospital
🇬🇧London, United Kingdom
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona - Barcelona, Spain
Hopital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Szpital Uniwersytecki w Krakowie
🇵🇱Kraków, Poland
Wojewódzki Szpital Zaka?ny
🇵🇱Warszawa, Poland
UCSF Fresno
🇺🇸Fresno, California, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Greenslopes Private Hospital
🇦🇺Greenslopes, Queensland, Australia
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
VA San Diego Healthcare
🇺🇸San Diego, California, United States
Huntington Medical Research Institutes
🇺🇸Pasadena, California, United States
Mayo Clinic Transplant Center
🇺🇸Jacksonville, Florida, United States
University of Colorado Health Sciences Ctr
🇺🇸Englewood, Colorado, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
GI & Liver Assoicates
🇺🇸Granbury, Texas, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
St George Hospital Clinical School of Medicine University of New South Wales
🇦🇺Kogarah, New South Wales, Australia
Austin Hospital
🇦🇺Heidelburg, Victoria, Australia
St Vincent's Hospital
🇦🇺Fitzroy, Victoria, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
McGill University
🇨🇦Montreal, Quebec, Canada
Albert-Ludwigs-Universitaet Freiburg
🇩🇪Freiburg, Germany
Hopital Henri Mondor
🇫🇷Creteil, France
Hopital Beaujon
🇫🇷Clichy, France
Hopital Saint-Joseph
🇫🇷Marseille Cedex 08, France
Hôpital de Brabois
🇫🇷Vandoeuvre, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Hopital Haut-Leveque
🇫🇷Pessac cedex, France
UH Charite Berlin / Virchow Klinikum
🇩🇪Berlin, Germany
UH Essen
🇩🇪Essen, Germany
Center for HIV and Hepatogastroenterology
🇩🇪Düsseldorf, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt / Main, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Dayanand Medical College and Hospital
🇮🇳Ludhiana, India
Paracelsus Klinik der Stadt Marl
🇩🇪Marl, Germany
Johannes Gutenberg-Universitaet Mainz
🇩🇪Mainz, Germany
Jaslok Hospital and Research Centre and Breach Candy Hospital,
🇮🇳Mumbai, India
Bnei-Zion Medical Center
🇮🇱Haifa, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Seconda Università di Napoli c/o Secondo Policlinico
🇮🇹Napoli, Italy
Policlinico S.Orsola Malpighi
🇮🇹Bologna, Italy
IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano
🇮🇹Milano, Italy
Casa Sollievo della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo (FG), Italy
I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia
🇮🇹Pavia, Italy
Szpital Specjalistyczny
🇵🇱Chorzow, Poland
Azienda Ospedaliera S. Giovanni Battista Molinette
🇮🇹Torino, Italy
Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego
🇵🇱Białystok, Poland
Wojewódzki Szpital Zespolony
🇵🇱Kielce, Poland
Spitalul Clinic Dr.Victor Babes
🇷🇴Bucharest, Romania
Institutul de Gastroenterologie si Hepatologie
🇷🇴Lasi, Romania
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Carlos III
🇪🇸Madrid, Spain
Queen Elizabeth Medical Centre
🇬🇧Birmingham, United Kingdom
Imperial College London St Mary's Hospital Campus
🇬🇧London, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Nottingham University Hospitals NHS Trust Queens Medical Centre Campus
🇬🇧Nottingham, United Kingdom
Scripps Clinic
🇺🇸La Jolla, California, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States