Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuferon | Drug | |||
| Ribavirin | Drug | |||
| PEG-IFNalfa2a | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA. | ||
| Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Concord Repatriation General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19447518 | Derived | Neumann AU, Pianko S, Zeuzem S, Yoshida EM, Benhamou Y, Mishan M, McHutchison JG, Pulkstenis E, Mani Subramanian G. Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naive patients with genotype 1, chronic hepatitis C. J Hepatol. 2009 Jul;51(1):21-8. doi: 10.1016/j.jhep.2009.01.017. Epub 2009 Mar 11. | |
| 18666223 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Undetectable HCV RNA at Week 24. |
| End of treatment response (ETR), defined as undetectable HCV RNA at Week 48 |
| Concord |
| New South Wales |
| 2139 |
| Australia |
| John Hunter Hospital | New Lambton Heights | New South Wales | 2305 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Royal Brisbane Hospital | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| St. Vincents Hospital | East Melbourne | Victoria | 3002 | Australia |
| Western Hospital | Footscray | Victoria | 3011 | Australia |
| Austin Health | Heidelberg | Victoria | 3081 | Australia |
| The Alfred | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| Fremantle Hospital | Fremantle | Western Australia | 6160 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
| University of Alberta | Edmonton | Alberta | T5H 4B9 | Canada |
| University of Alberta- Liver Unit | Edmonton | Alberta | T6G 2C8 | Canada |
| University of British Columbia | Vancouver | British Columbia | V6T 1Z4 | Canada |
| University of Manitoba | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Dalhousie University | Halifax | Nova Scotia | B3H2Y9 | Canada |
| McMaster Clinic - Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| University of Western Ontario | London | Ontario | N6A5A5 | Canada |
| Ottawa Civic Hospital | Ottawa | Ontario | K1S 0W8 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| University of Saskatchewan | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| FN Bohunice | Brno | 62500 | Czechia |
| Klinika infekcnich nemoci | Hradec Králové | 50005 | Czechia |
| Nemocnice s poliklinikou Melnik | Mělník | 27601 | Czechia |
| Slezska nemocnice | Opava | 74601 | Czechia |
| Vseobecna fakultni nemocnice | Prague | 12808 | Czechia |
| Nuselska poliklinika - Remedis | Prague | 14000 | Czechia |
| Fakultni Thomayerova nemocnice | Prague | 14059 | Czechia |
| Ambulance pro interni a infekcni nemoci | Ústí nad Labem | 40001 | Czechia |
| University of Angers, CHU Angers | Angers | 49033 | France |
| University of Clichy, Hopital Beaujon | Clichy | 92110 | France |
| University of Creteil, Hopital Henri Mondor | Créteil | 94010 | France |
| University of Grenoble, Hopital Nord | Grenoble | 38043 | France |
| University of Lille, Hopital Claude Huriez | Lille | 59037 | France |
| University of Lyon, Hopital de l'Hotel Dieu | Lyon | 69288 | France |
| University of Marseille, Hopital Saint Joseph | Marseille | 13285 | France |
| University of Nice, Hopital de l'Archet | Nice | 06202 | France |
| University of Orleans, Hopital de la Source | Orléans | 45100 | France |
| University of Paris, Hopital Saint-Antoine | Paris | 75012 | France |
| University of Paris, Hopital Pitie-Salpetriere | Paris | 75013 | France |
| University of Paris, Hopital Necker | Paris | 75743 | France |
| Hopital Haut-Leveque | Pessac | 33600 | France |
| University of Toulouse, Clinique Dieulafoy | Toulouse | 31059 | France |
| Hopital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| University of Berlin, Charite Campus Virchow Klinikum | Berlin | 13353 | Germany |
| University of Bochum, Kliniken Bergmannsheil | Bochum | 44892 | Germany |
| University of Duesseldorf | Düsseldorf | 40255 | Germany |
| University of Essen | Essen | 45122 | Germany |
| University of Frankfurt | Frankfurt | 60590 | Germany |
| University of Freiburg | Freiburg im Breisgau | 79106 | Germany |
| University of Hamburg, Hospital Hamburg Eppendorf | Hamburg | 20246 | Germany |
| University of Hannover | Hanover | 30625 | Germany |
| University of Heidelberg | Heidelberg | 69120 | Germany |
| University of Saarland | Homburg | 66421 | Germany |
| University of Kiel | Kiel | 24105 | Germany |
| University of Leipzig | Leipzig | 04103 | Germany |
| University of Mainz | Mainz | 55131 | Germany |
| University of Tuebingen | Tübingen | 72076 | Germany |
| B´nai-Zion Medical Center | Haifa | 31048 | Israel |
| Rambam Medical Center | 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 |
| Oddzial Chorob Watroby | Bialystok | 15-540 | Poland |
| Katedra i Klinika Chorob Zakaznych i Hepatologii | Bydgoszcz | 85-030 | Poland |
| Katedra i Oddzial Kliniczny Chorob Zakaznych | Chorzów | 41-500 | Poland |
| Wojewodzki Szpital Zespolony | Kielce | 24-317 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31-531 | Poland |
| Klinika Obserwacyjno Zakazna | Lodz | 91-347 | Poland |
| Oddzial Zakazny | Poznan | 61-003 | Poland |
| Katedra i Klinika Chorob Zakaznych | Szczecin | 71-455 | Poland |
| I Oddzial Dzienny SPZOZ | Warsaw | 01-201 | Poland |
| Klinika Hepatologii i Nabytych Niedoborow Immunologicznych | Warsaw | 01-201 | Poland |
| Katedra i Klinika Chorob Zakaznych | Wroclaw | 51-149 | Poland |
| Spitalul Clinic Colentina | Bucharest | 20125 | Romania |
| Institutul Clinic Fundeni | Bucharest | 22328 | Romania |
| Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes" | Bucharest | 30303 | Romania |
| Spitalul Clinic de Adulti Cluj-Napoca | Cluj-Napoca | 400162 | Romania |
| Institutul de Gastroenterologie si Hepatologie | Iași | 700111 | Romania |
| Derived |
| Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17. doi: 10.1002/hep.22403. |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C473631 | albuferon |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided