Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
NCT ID: NCT00411385
Last Updated: 2013-08-08
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
933 participants
INTERVENTIONAL
2007-02-28
2008-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
Ribavirin
800mg/day for 24 weeks
2
1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
Ribavirin
800mg/day for 24 weeks
3
180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
peginterferon alfa-2a
180 micrograms Pegasys given subcutaneaously once a week for 24 weeks
Ribavirin
800mg/day for 24 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
peginterferon alfa-2a
180 micrograms Pegasys given subcutaneaously once a week for 24 weeks
Ribavirin
800mg/day for 24 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
INDUSTRY
Human Genome Sciences Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Hospital
Phoenix, Arizona, United States
Scripps Clinic
La Jolla, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
University of Florida-Gainesville
Gainesville, Florida, United States
Shands Jacksonville Medical Center
Jacksonville, Florida, United States
Mayo Clinic Transplant Center
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
GI of Atlanta
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Johns Hopkins Center for Viral Hepatits
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of New Mexico
Albuquerque, New Mexico, United States
New York Hospital - Cornell
New York, New York, United States
Faculty Practice Associates
New York, New York, United States
NY Presbyterian Medical Center - Columbia Univ. Med Center
New York, New York, United States
Bronx VA Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Alamo Medrical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Unidad de Hepatología
Capital Federal, Buenos Aires, Argentina
Fundación Cidea
Capital Federal, Buenos Aires, Argentina
Hospital Italiano
Capital Federal, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Htal Pcial del Centenario
Rosario, Santa Fe Province, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
St George Hospital Clinical School of Medicine
Kogarah, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Gallipoli Research Foundation and Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Royal Bribane & Women's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St Vincent's Hospital
Fitzroy, Victoria, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Austin Hospital
Heidelburg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
CHU Brugmann ULB - site Victor Horta
Brussels, , Belgium
UCL
Brussels, , Belgium
University Hospital Antwerp
Edegem, , Belgium
Ghent University Hospital
Ghent, , Belgium
CHU Sart Tilman
Liège, , Belgium
Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia
Salvador, Estado de Bahia, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
Universidade Federal de São Paulo - UNIFESP
São Paulo, São Paulo, Brazil
Hospital Heliópolis
São Paulo, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Heritage Medical Research Clinic
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada
University of Western Ontario Hospital
London, Ontario, Canada
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
McGill University
Montreal, Quebec, Canada
Hopital Beaujon
Clichy, , France
Hopital Henri Mondor
Créteil, , France
CHU de Lyon, Hôpital de l'Hôtel Dieu
Lyon, , France
Hopital Saint-Joseph
Marseille, , France
Hopital de La Source
Orléans, , France
Hôpital Saint-Antoine
Paris, , France
Hopital Pitie-Salpetriere
Paris, , France
Hopital Haut-Leveque
Pessac, , France
CHU Purpan Clinique Dieulafoy
Toulouse, , France
Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
UH Charite Berlin / Virchow Klinikum
Berlin, , Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, , Germany
Universitätsklinik Düsseldorf
Düsseldorf, , Germany
UH Essen
Essen, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, , Germany
Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Paracelsus Klinik der Stadt Marl
Marl, , Germany
Dayanand Medical College and Hospital
Ludhiana, , India
Jaslok Hospital and Research Centre and Breach Candy Hospital,
Mumbai, , India
P. D. Hinduja National Hospital and Medical Research Centre
Mumbai, , India
G.B.Pant Hospital
New Delhi, , India
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi, , India
Bnei-Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
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
Hospital Alor Setar
Alor Star, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
HUKM
Kuala Lumpur, , Malaysia
Hospital Selayang
Kuala Selangor, , Malaysia
Hosp. Universitario. Monterrey
Monterrey N.L., CP, Mexico
Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"
Mexico City, Mexico City, Mexico
Clínica Lomas Altas
Mexico City, , Mexico
Wojewódzki Szpital Specjalistyczny
Bialystok, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Czeladź, , Poland
Wojewódzki Szpital Zespolony
Kielce, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Uniwersytet Medyczny
Lodz, , Poland
Wojewódzki Szpital Zakaźny
Warsaw, , Poland
Przychodnia przy Łowieckie
Wroclaw, , Poland
Fundacion de Investigacion de Diego
Santurce, , Puerto Rico
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
CGH
Singapore, , Singapore
Bundang CHA Hospital
Bundang, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Seoul National University Hospital(Bundang)
Seonnam City, , South Korea
Severance Hospital(SVR)
Seoul, , South Korea
Kyunghee University - Medical center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Yongdong Severance Hospital
Seoul, , South Korea
Korea University Medical Center(Anam)
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Medical Center(Guro)
Seoul, , South Korea
Aju University Hospital
Suwon, , South Korea
Hospital Universitari Germans Trias i Pujol
Badalona - Barcelona, , Spain
Hopital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Carlos III
Madrid, , Spain
Complejo Hospitalario Nuestra Señora de Valme
Seville, , Spain
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Universitetssjukhuset MAS
Malmo, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
TCGH-HL
Hualien City, R.o.c., Taiwan
KMUH
Kaohsiung City, R.o.c., Taiwan
KCGMH
Kaohsiung City, R.o.c., Taiwan
VGH-TC
Taichung, R.o.c., Taiwan
NTUH
Taipei, R.o.c., Taiwan
TSGH
Taipei, R.o.c., Taiwan
CGMH-LK
Taoyuan District, R.o.c., Taiwan
CCH
Changhua, , Taiwan
CMUH
Taichung, , Taiwan
NCKUH
Tainan City, , Taiwan
CMMC
Tainan City, , Taiwan
TCGH-TP
Taipei, , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, , Thailand
Barts and the London NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bain VG, Yoshida EM, Kaita KD, Swain MG, Heathcote EJ, Garcia A, Moore PA, Yu R, McHutchison JG, Subramanian GM. Dynamics of interferon-specific gene expression in peripheral blood of interferon alfa-naive patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. doi: 10.1016/j.hepres.2006.04.005. Epub 2006 May 30.
Bain VG, Kaita KD, Yoshida EM, Swain MG, Heathcote EJ, Neumann AU, Fiscella M, Yu R, Osborn BL, Cronin PW, Freimuth WW, McHutchison JG, Subramanian GM. A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. J Hepatol. 2006 Apr;44(4):671-8. doi: 10.1016/j.jhep.2005.12.011. Epub 2006 Jan 30.
S. Zeuzem, , Y. Benhamou, , D. Shouval, , V. Bain, S. Pianko, , R. Flisiak, , M. Grigorescu, , V. Rehak, , E. Yoshida, K. Kaita, , C. Hezode, A.U. Neumann, M. Subramanian, J. McHutchison. Interim (Week 12) Phase 2B Virological Efficacy and Safety Results of albumin interferon alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection. EASL, 2006
Vinod Rustgi, et al. A Dose-Escalation Study of albumin alfa-Ribavirin in Non-responders to Prior Interferon Based Therapy for Chronic Hepatitis C Infection Phase 2 Dose A Phase 2 Dose-Escalation Study of albumin interferon alfa interferon alfa-2b Combined with 2b Combined with Ribavirin in Non Non-responders to Prior Interferon. EASL, 2006
Balan V, Nelson DR, Sulkowski MS, Everson GT, Lambiase LR, Wiesner RH, Dickson RC, Post AB, Redfield RR, Davis GL, Neumann AU, Osborn BL, Freimuth WW, Subramanian GM. A Phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy. Antivir Ther. 2006;11(1):35-45.
Nelson DR, Benhamou Y, Chuang WL, Lawitz EJ, Rodriguez-Torres M, Flisiak R, Rasenack JW, Kryczka W, Lee CM, Bain VG, Pianko S, Patel K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-2/3 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3. Gastroenterology. 2010 Oct;139(4):1267-76. doi: 10.1053/j.gastro.2010.06.062. Epub 2010 Jul 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACHIEVE-2/3
Identifier Type: -
Identifier Source: secondary_id
HGS1008-C1067
Identifier Type: -
Identifier Source: org_study_id