Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.
2 other identifiers
interventional
933
21 countries
159
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 14, 2006
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedAugust 8, 2013
August 1, 2013
1.7 years
December 13, 2006
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained virologic response (SVR)
Week 48
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
2
EXPERIMENTAL1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
3
ACTIVE COMPARATOR180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
Interventions
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Human Genome Sciences Inc.lead
- Novartiscollaborator
Study Sites (159)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Scripps Clinic
La Jolla, California, 92037, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of Colorado
Denver, Colorado, 80262-0001, United States
University of Florida-Gainesville
Gainesville, Florida, 32610, United States
Shands Jacksonville Medical Center
Jacksonville, Florida, 32209, United States
Mayo Clinic Transplant Center
Jacksonville, Florida, 32216, United States
University of Miami
Miami, Florida, 33136-1051, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308, United States
GI of Atlanta
Atlanta, Georgia, 30309, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Johns Hopkins Center for Viral Hepatits
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, 55446, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
New York Hospital - Cornell
New York, New York, 10021, United States
Faculty Practice Associates
New York, New York, 10029, United States
NY Presbyterian Medical Center - Columbia Univ. Med Center
New York, New York, 10032, United States
Bronx VA Medical Center
The Bronx, New York, 10468, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7584, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604-3200, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Alamo Medrical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Unidad de Hepatología
Capital Federal, Buenos Aires, C1093AAS, Argentina
Fundación Cidea
Capital Federal, Buenos Aires, C1121ABE, Argentina
Hospital Italiano
Capital Federal, Buenos Aires, C1181ACH, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629AHJ, Argentina
Htal Pcial del Centenario
Rosario, Santa Fe Province, 2000, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
St George Hospital Clinical School of Medicine
Kogarah, New South Wales, 2217, Australia
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Gallipoli Research Foundation and Greenslopes Private Hospital
Greenslopes, Queensland, 4120, Australia
Royal Bribane & Women's Hospital
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
St Vincent's Hospital
Fitzroy, Victoria, Victoria, 3065, Australia
Western Hospital
Footscray, Victoria, 3011, Australia
Austin Hospital
Heidelburg, Victoria, 3081, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
CHU Brugmann ULB - site Victor Horta
Brussels, 1020, Belgium
UCL
Brussels, 1200, Belgium
University Hospital Antwerp
Edegem, 2650, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia
Salvador, Estado de Bahia, 40110-170, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14049-900, Brazil
Universidade Federal de São Paulo - UNIFESP
São Paulo, São Paulo, 04023-900, Brazil
Hospital Heliópolis
São Paulo, São Paulo, 04230-000, Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000, Brazil
Heritage Medical Research Clinic
Calgary, Alberta, T2N 4N1, Canada
University of Alberta
Edmonton, Alberta, T5H 4B9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 3P1, Canada
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, R3E 3P4, Canada
University of Western Ontario Hospital
London, Ontario, N6A 5A5, Canada
Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
McGill University
Montreal, Quebec, H3A 1A1, Canada
Hopital Beaujon
Clichy, 92110, France
Hopital Henri Mondor
Créteil, 94010, France
CHU de Lyon, Hôpital de l'Hôtel Dieu
Lyon, 69288, France
Hopital Saint-Joseph
Marseille, 13285, France
Hopital de La Source
Orléans, 45100, France
Hôpital Saint-Antoine
Paris, 75012, France
Hopital Pitie-Salpetriere
Paris, 75013, France
Hopital Haut-Leveque
Pessac, 33600, France
CHU Purpan Clinique Dieulafoy
Toulouse, 31059, France
Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511, France
UH Charite Berlin / Virchow Klinikum
Berlin, 13353, Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, 40237, Germany
Universitätsklinik Düsseldorf
Düsseldorf, 40255, Germany
UH Essen
Essen, 45122, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, 60590, Germany
Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, 79106, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, 30623, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Leipzig
Leipzig, 4103, Germany
Johannes Gutenberg-Universitaet Mainz
Mainz, 55101, Germany
Paracelsus Klinik der Stadt Marl
Marl, 45770, Germany
Dayanand Medical College and Hospital
Ludhiana, 141001, India
Jaslok Hospital and Research Centre and Breach Candy Hospital,
Mumbai, 400 0026, India
P. D. Hinduja National Hospital and Medical Research Centre
Mumbai, 400 016, India
G.B.Pant Hospital
New Delhi, 110 002, India
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi, 110 002, India
Bnei-Zion Medical Center
Haifa, 31048, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Hadassah Medical Organization
Jerusalem, 91120, Israel
Holy Family Hospital
Nazareth, 16100, Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Hospital Alor Setar
Alor Star, 5150, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 50603, Malaysia
HUKM
Kuala Lumpur, 56000, Malaysia
Hospital Selayang
Kuala Selangor, 68100, Malaysia
Hosp. Universitario. Monterrey
Monterrey N.L., CP, 64460, Mexico
Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"
Mexico City, Mexico City, 14000, Mexico
Clínica Lomas Altas
Mexico City, 11950, Mexico
Wojewódzki Szpital Specjalistyczny
Bialystok, 15-540, Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Czeladź, 41-250, Poland
Wojewódzki Szpital Zespolony
Kielce, 25-317, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-531, Poland
Uniwersytet Medyczny
Lodz, 91-347, Poland
Wojewódzki Szpital Zakaźny
Warsaw, 01-201, Poland
Przychodnia przy Łowieckie
Wroclaw, 50-220, Poland
Fundacion de Investigacion de Diego
Santurce, 909, Puerto Rico
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
CGH
Singapore, 529889, Singapore
Bundang CHA Hospital
Bundang, 463-712, South Korea
Kyungpook National University Hospital
Daegu, 700-721, South Korea
Pusan National University Hospital
Pusan, 602-739, South Korea
Seoul National University Hospital(Bundang)
Seonnam City, 463-802, South Korea
Severance Hospital(SVR)
Seoul, 120-752, South Korea
Kyunghee University - Medical center
Seoul, 130-702, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Yongdong Severance Hospital
Seoul, 135-720, South Korea
Korea University Medical Center(Anam)
Seoul, 136-705, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Korea University Medical Center(Guro)
Seoul, 152-703, South Korea
Aju University Hospital
Suwon, 443-821, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona - Barcelona, 8916, Spain
Hopital Universitari Vall d'Hebron
Barcelona, 8035, Spain
Hospital Clinic i Provincial
Barcelona, 8036, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Carlos III
Madrid, 28029, Spain
Complejo Hospitalario Nuestra Señora de Valme
Seville, 41014, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Universitetssjukhuset MAS
Malmo, 205 02, Sweden
Karolinska Universitetssjukhuset
Stockholm, 171 76, Sweden
TCGH-HL
Hualien City, R.o.c., 970, Taiwan
KMUH
Kaohsiung City, R.o.c., 807, Taiwan
KCGMH
Kaohsiung City, R.o.c., 833, Taiwan
VGH-TC
Taichung, R.o.c., 407, Taiwan
NTUH
Taipei, R.o.c., 100, Taiwan
TSGH
Taipei, R.o.c., 114, Taiwan
CGMH-LK
Taoyuan District, R.o.c., 333, Taiwan
CCH
Changhua, 500, Taiwan
CMUH
Taichung, 404, Taiwan
NCKUH
Tainan, 704, Taiwan
CMMC
Tainan, 710, Taiwan
TCGH-TP
Taipei, 231, Taiwan
Chulalongkorn Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, 50200, Thailand
Barts and the London NHS Trust
London, E1 2AT, United Kingdom
Related Publications (6)
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.
PMID: 16731032BACKGROUNDBain 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.
PMID: 16487617BACKGROUNDS. 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
BACKGROUNDVinod 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
BACKGROUNDBalan 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.
PMID: 16518958BACKGROUNDNelson 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.
PMID: 20600017DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2006
First Posted
December 14, 2006
Study Start
February 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
August 8, 2013
Record last verified: 2013-08