Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients
Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1
2 other identifiers
interventional
1,331
14 countries
162
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2006
162 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedAugust 8, 2013
August 1, 2013
2.2 years
November 20, 2006
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained virologic response (SVR)
Week 72
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATOR180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day
2
EXPERIMENTAL900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
3
EXPERIMENTAL1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Interventions
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 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.
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 (165)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
UCSF Fresno
Fresno, California, 93702, United States
Scripps Clinic
La Jolla, California, 92037, United States
USC Keck School of Medicine
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA / West LA VAMC
Los Angeles, California, 90073, United States
Huntington Medical Research Institutes
Pasadena, California, 91105, United States
University California-San Diego
San Diego, California, 92103-8707, United States
San Diego Digestive Diseases Consultants, Inc
San Diego, California, 92123, United States
VA San Diego Healthcare
San Diego, California, 92161, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of California at San Francisco
San Francisco, California, 94143-0538, United States
University of Colorado
Denver, Colorado, 80262-0001, United States
University of Colorado Health Sciences Ctr
Englewood, Colorado, 80113, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, 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
Va Health Care System
Miami, Florida, 33125, United States
University of Miami
Miami, Florida, 33136-1051, United States
Venture Research Institute
North Miami Beach, Florida, 33162, United States
University Hepatitis Center
Sarasota, Florida, 34243, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308, United States
GI of Atlanta
Atlanta, Georgia, 30309, United States
Northwest Georgia Gastroenterology Associates
Marietta, Georgia, 30060, United States
Alan D Tice, MD, LLC
Honolulu, Hawaii, 96813, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Indiania University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21021-1544, United States
Johns Hopkins Center for Viral Hepatits
Baltimore, Maryland, 21287, United States
Maryland Digestive Disease Center
Laurel, Maryland, 20707, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Digestive Health Specialist
Tupelo, Mississippi, 38801, United States
St. Louis University
St Louis, Missouri, 63104, United States
University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
New York Hospital - Cornell
New York, New York, 10021, United States
Faculty Practice Associates
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7584, United States
Duke Medical Center
Durham, North Carolina, 27705, United States
University of Cincinnati
Cincinnati, Ohio, 95267-0595, United States
Hospital of University of PA
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Memphis Gastroenterology Group
Germantown, Tennessee, 38138, United States
Nashville Gastroenterology
Nashville, Tennessee, 37205, United States
Nashville Gastrointestinal Specialists
Nashville, Tennessee, 37211, United States
Liver Institute at Methodist Dallas
Dallas, Texas, 75208, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Southwesten Medical Center
Dallas, Texas, 75390-8887, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
GI & Liver Assoicates
Granbury, Texas, 76048, United States
Liver Specialist of Texas
Houston, Texas, 77030-2312, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
INOVA Fairfax Hospital
Annandale, Virginia, 22003, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Virginia Commonwealth University Medical Ctr
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98195-6174, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792-5124, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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 University of New South Wales
Kogarah, New South Wales, 2217, Australia
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, 4120, 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
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, 6000, Australia
Medizinische Universitätsklinik Graz
Graz, 8036, Austria
Univ.-Klinik fuer Innere Medizin
Innsbruck, 6020, Austria
Medical University of Vienna
Vienna, 1090, Austria
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
Dalhousie University
Halifax, Nova Scotia, B3H 2Y9, 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
Klinika infekcních chorob
Brno, 62500, Czechia
Klinika Infekcních nemocí
Hradec Králové, 50005, Czechia
Nemocnice s poliklinikou Melník
Mělník, 27601, Czechia
Slezská nemocnice
Opava, 74601, Czechia
Vseobecna fakultní nemocnice
Prague, 12808, Czechia
Nuselská poliklinika
Prague, 14000, Czechia
Ambulance pro interni a infekcni nemoci
Ústí nad Labem, 40001, Czechia
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
G.B.Pant 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
Policlinico S.Orsola Malpighi
Bologna, 40138, Italy
IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano
Milan, 20122, Italy
Seconda Università di Napoli c/o Secondo Policlinico
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia
Pavia, 27100, Italy
Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo (FG), 71013, Italy
Azienda Ospedaliera S. Giovanni Battista Molinette
Torino, 10126, Italy
Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego
Bialystok, 15-540, Poland
Szpital Specjalistyczny
Chorzów, 41-500, Poland
Wojewódzki Szpital Zespolony
Kielce, 25-317, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-531, Poland
Uniwersytet Medyczny
Lodz, 91-347, Poland
Akademia Medyczna
Warsaw, 01-201, Poland
Wojewódzki Szpital Zaka?ny
Warsaw, 01-201, Poland
Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego
Wroclaw, 51-149, Poland
Fundacion de Investigacion de Diego
Santurce, 909, Puerto Rico
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Institutul Clinic Fundeni
Bucharest, 22328, Romania
Spitalul Clinic Dr.Victor Babes
Bucharest, 30303, Romania
Spitalul Clinic de Adulti Cluj-Napoca
Cluj-Napoca, 400162, Romania
Institutul de Gastroenterologie si Hepatologie
Lasi, 700111, Romania
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
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Queen Elizabeth Medical Centre
Birmingham, B15 2TH, United Kingdom
Royal London Hospital
London, E1 2AT, United Kingdom
Imperial College London St Mary's Hospital Campus
London, W2 1PG, United Kingdom
Nottingham University Hospitals NHS Trust Queens Medical Centre Campus
Nottingham, NG7 2UH, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, 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: 16518958BACKGROUNDZeuzem S, Sulkowski MS, Lawitz EJ, Rustgi VK, Rodriguez-Torres M, Bacon BR, Grigorescu M, Tice AD, Lurie Y, Cianciara J, Muir AJ, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-1 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 1. Gastroenterology. 2010 Oct;139(4):1257-66. doi: 10.1053/j.gastro.2010.06.066. Epub 2010 Jun 27.
PMID: 20600013DERIVED
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
November 20, 2006
First Posted
November 22, 2006
Study Start
December 1, 2006
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
August 8, 2013
Record last verified: 2013-08