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| ID | Type | Description | Link |
|---|---|---|---|
| ACHIEVE-2/3 |
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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 2/3 who are IFNa treatment naive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day |
|
| 2 | Experimental | 1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day |
|
| 3 | Active Comparator | 180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albumin interferon alfa-2b | Drug | 900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR) | Week 48 |
| 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 |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States | ||
| Scripps Clinic |
| 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 micrograms Pegasys given subcutaneaously once a week for 24 weeks |
|
| Ribavirin | Drug | 800mg/day for 24 weeks |
|
| 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 |
| 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 | Malmö | 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 | 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 |
| 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. |
| 20600017 | Derived | 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. |
| 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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