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| ID | Type | Description | Link |
|---|---|---|---|
| ACHIEVE-1 | Other Identifier | Human Genome Sciences Inc. |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day |
|
| 2 | Experimental | 900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day |
|
| 3 | Experimental | 1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albumin interferon alfa-2b | Drug | 900 mcg or 1200mcg every two week for 48 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR) | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Rapid virologic response | Week 4 | |
| Early virologic response | Week 12 | |
| Undetectable HCV RNA |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16731032 | Background | 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. | |
| 16487617 |
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| peginterferon alfa-2a |
| Drug |
180 mcg once a week for 48 weeks |
|
| Ribavirin | Drug | 1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects =,> 75kg) |
|
| 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 |
| 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 | Naples | 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 |
| Background |
| 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. |
| Background | 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 |
| Background | 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 |
| 16518958 | Background | 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. |
| 20600013 | Derived | Zeuzem 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. |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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