Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT00411385
- 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 2/3 who are IFNa treatment naive.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 933
- Diagnosis of chronic hepatitis C.
- Liver biopsy performed within 2 years of Day 0 or during screening.
- Infected with hepatitis C virus genotype 2/3.
- 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 1 Ribavirin 900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day 2 albumin interferon alfa-2b 1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day 1 albumin interferon alfa-2b 900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day 2 Ribavirin 1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day 3 Ribavirin 180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day 3 peginterferon alfa-2a 180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
- Primary Outcome Measures
Name Time Method Sustained virologic response (SVR) Week 48
- Secondary Outcome Measures
Name Time Method Rapid virologic response Week 4 Early virologic response Week 12 Undetectable HCV RNA Week 24 Normalization of ALT (a liver enzyme) Week 48 Quality of life evaluation Week 48 Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results) Througout the entire treatment period
Trial Locations
- Locations (159)
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
GI of Atlanta
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Center for Viral Hepatits
🇺🇸Baltimore, Maryland, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
John Hunter Hospital
🇦🇺New Lambton, New South Wales, Australia
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
CHU Brugmann ULB - site Victor Horta
🇧🇪Brussels, Belgium
CMMC
🇨🇳Tainan, Taiwan
KCGMH
🇨🇳Kaohsiung, R.o.c., Taiwan
KMUH
🇨🇳Kaohsiung, R.o.c., Taiwan
Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"
🇲🇽Mexico, DF, Mexico
VGH-TC
🇨🇳Taichung, R.o.c., Taiwan
CMUH
🇨🇳Taichung, Taiwan
Siriraj Hospital
🇹🇭Bangkok, Thailand
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
TCGH-HL
🇨🇳Hualien, R.o.c., Taiwan
CGH
🇸🇬Singapore, Singapore
CCH
🇨🇳Changhua, Taiwan
NTUH
🇨🇳Taipei, R.o.c., Taiwan
Hospital Alor Setar
🇲🇾Alor Setar, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Hosp. Universitario. Monterrey
🇲🇽Monterrey N.L., CP, Mexico
Singapore General Hospital
🇸🇬Singapore, Singapore
Chulalongkorn Hospital
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
🇹🇭Chiang Mai, Thailand
TCGH-TP
🇨🇳Taipei, Taiwan
UCL
🇧🇪Brussels, Belgium
University of Colorado
🇺🇸Denver, Colorado, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Alamo Medrical Research
🇺🇸San Antonio, Texas, United States
McGill University
🇨🇦Montreal, Quebec, Canada
NCKUH
🇨🇳Tainan, Taiwan
Mayo Clinic Transplant Center
🇺🇸Jacksonville, Florida, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
University of Florida-Gainesville
🇺🇸Gainesville, Florida, United States
Shands Jacksonville Medical Center
🇺🇸Jacksonville, Florida, United States
University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
NY Presbyterian Medical Center - Columbia Univ. Med Center
🇺🇸New York, New York, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Htal Pcial del Centenario
🇦🇷Rosario, Santa Fe, Argentina
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Hospital Italiano
🇦🇷Capital Federal, Buenos Aires, Argentina
University of Manitoba Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
Universidade Federal de São Paulo - UNIFESP
🇧🇷São Paulo, SP, Brazil
Unidad de Hepatología
🇦🇷Capital Federal, Buenos Aires, Argentina
CHU Sart Tilman
🇧🇪Liège, Belgium
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
University of Miami
🇺🇸Miami, Florida, United States
Ghent University Hospital
🇧🇪Gent, Belgium
Hopital de La Source
🇫🇷Orleans, France
Hôpital de Brabois
🇫🇷Vandoeuvre, France
St Vincent's Hospital
🇦🇺Fitzroy, Victoria, Victoria, Australia
University Hospital Antwerp
🇧🇪Edegem, Belgium
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Hospital Universitario Austral
🇦🇷Pilar, Buenos Aires, Argentina
Western Hospital
🇦🇺Footscray, Victoria, Australia
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Dayanand Medical College and Hospital
🇮🇳Ludhiana, India
P. D. Hinduja National Hospital and Medical Research Centre
🇮🇳Mumbai, India
Hospital Heliópolis
🇧🇷São Paulo, SP, Brazil
Maulana Azad Medical College and Associated Lok Nayak Hospital
🇮🇳New Delhi, India
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Center for HIV and Hepatogastroenterology
🇩🇪Düsseldorf, Germany
G.B.Pant Hospital
🇮🇳New Delhi, India
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
CHU de Lyon, Hôpital de l'Hôtel Dieu
🇫🇷Lyon Cedex 02, France
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Johannes Gutenberg-Universitaet Mainz
🇩🇪Mainz, Germany
Jaslok Hospital and Research Centre and Breach Candy Hospital,
🇮🇳Mumbai, India
Paracelsus Klinik der Stadt Marl
🇩🇪Marl, Germany
HUKM
🇲🇾Kuala Lumpur, Malaysia
Clínica Lomas Altas
🇲🇽Mexico City, Mexico
National University Hospital
🇸🇬Singapore, Singapore
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Selayang
🇲🇾Selangor, Malaysia
Wojewódzki Szpital Zakaźny
🇵🇱Warszawa, Poland
CGMH-LK
🇨🇳Taoyuan, R.o.c., Taiwan
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Royal Bribane & Women's Hospital
🇦🇺Herston, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Regional Gastroenterology Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia
🇧🇷Salvador, BA, Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
🇧🇷São Paulo, SP, Brazil
Heritage Medical Research Clinic
🇨🇦Calgary, Alberta, Canada
Hopital Henri Mondor
🇫🇷Creteil, France
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Rambam Health Care Campus
🇮🇱Haifa, Israel
Hopital Saint-Joseph
🇫🇷Marseille Cedex 08, France
Holy Family Hospital
🇮🇱Nazareth, Israel
New York Hospital - Cornell
🇺🇸New York, New York, United States
Bronx VA Medical Center
🇺🇸Bronx, New York, United States
Faculty Practice Associates
🇺🇸New York, New York, United States
Minnesota Gastroenterology, P.A.
🇺🇸Plymouth, Minnesota, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Gallipoli Research Foundation and Greenslopes Private Hospital
🇦🇺Greenslopes, Queensland, Australia
Fundación Cidea
🇦🇷Capital Federal, Buenos Aires, Argentina
St George Hospital Clinical School of Medicine
🇦🇺Kogarah, New South Wales, Australia
Austin Hospital
🇦🇺Heidelburg, Victoria, Australia
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷Ribeirão Preto, SP, Brazil
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
University of Western Ontario Hospital
🇨🇦London, Ontario, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
UH Essen
🇩🇪Essen, Germany
Hopital Beaujon
🇫🇷Clichy, France
Universitätsklinik Düsseldorf
🇩🇪Duesseldorf, Germany
Albert-Ludwigs-Universitaet Freiburg
🇩🇪Freiburg, Germany
Hôpital Saint-Antoine
🇫🇷Paris, France
UH Charite Berlin / Virchow Klinikum
🇩🇪Berlin, Germany
Hopital Haut-Leveque
🇫🇷Pessac cedex, France
CHU Purpan Clinique Dieulafoy
🇫🇷Toulouse Cedex, France
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt / Main, Germany
Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Germany
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Bnei-Zion Medical Center
🇮🇱Haifa, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Rabin Medical Center Beilinson Campus
🇮🇱Petach Tikva, Israel
Bundang CHA Hospital
🇰🇷Bundang, Korea, Republic of
Seoul National University Hospital(Bundang)
🇰🇷Seonnam City, Korea, Republic of
Severance Hospital(SVR)
🇰🇷Seoul, Korea, Republic of
Kyunghee University - Medical center
🇰🇷Seoul, Korea, Republic of
Korea University Medical Center(Anam)
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Aju University Hospital
🇰🇷Suwon, Korea, Republic of
Korea University Medical Center(Guro)
🇰🇷Seoul, Korea, Republic of
Niepubliczny Zaklad Opieki Zdrowotnej
🇵🇱Czeladz, Poland
Przychodnia przy Łowieckie
🇵🇱Wroclaw, Poland
Wojewódzki Szpital Specjalistyczny
🇵🇱Bialystok, Poland
Wojewódzki Szpital Zespolony
🇵🇱Kielce, Poland
Szpital Uniwersytecki w Krakowie
🇵🇱Krakow, Poland
Uniwersytet Medyczny
🇵🇱Lodz, Poland
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Hopital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona - Barcelona, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Complejo Hospitalario Nuestra Señora de Valme
🇪🇸Sevilla, Spain
Hospital Carlos III
🇪🇸Madrid, Spain
Universitetssjukhuset MAS
🇸🇪Malmö, Sweden
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
TSGH
🇨🇳Taipei, R.o.c., Taiwan
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Barts and the London NHS Trust
🇬🇧London, United Kingdom
Yongdong Severance Hospital
🇰🇷Seoul, Korea, Republic of
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States