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This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | GS-9190 and GS-9256 in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy |
|
| Arm 2 | Experimental | GS-9256 (active) and placebo matching GS-9190 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy |
|
| Arm 3 | Placebo Comparator | Placebo matching GS-9190 and placebo matching GS-9256 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-9190 | Drug | GS-9190 capsule, 20 mg BID, 16 or 24 weeks |
| |
| GS-9256 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation | 24 weeks of off-treatment follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events | Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-up | |
| Emergence of viral resistance following initiation of therapy with GS-9190 and GS-9256 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bittoo Kanwar | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| Advanced Clinical Research Institute |
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| Drug |
GS-9256 capsule, 150 mg BID, 16 or 24 weeks |
|
| Pegasys® | Biological | peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks |
|
| Copegus® | Drug | ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks |
|
| GS-9190 placebo | Drug | placebo matching GS-9190 capsule BID, 24 weeks |
|
| GS-9256 | Drug | GS-9256 capsule, 150 mg BID, 24 weeks |
|
| Pegasys® | Biological | peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks |
|
| Copegus® | Drug | ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks |
|
| GS-9190 placebo | Drug | placebo matching GS-9190 capsule BID, 24 weeks |
|
| GS-9256 placebo | Drug | placebo matching GS-9256 capsule BID, 24 weeks |
|
| Pegasys® | Biological | peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks |
|
| Copegus® | Drug | ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks |
|
| Through up to 48 weeks treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry Substudy |
| Viral dynamics and steady state pharmacokinetics of GS-9190 and GS-9256 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9256 over time | Through Week 4 of therapy |
| Long-term assessment of plasma HCV RNA in subjects who achieve SVR | Plasma HCV RNA will be measured at approximately 6, 12, 24, and 36 months after Week 72. | 36 months following Week 72 |
| Anaheim |
| California |
| 92801 |
| United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| Kaiser Permanente | San Diego | California | 92154 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| South Denver Gastroenterology | Englewood | Colorado | 80110 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami Center for Liver Diseases | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Bach and Godofsky Infectious Diseases | Sarasota | Florida | 34243 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | United States |
| Emory University, Infectious Disease Clinic | Atlanta | Georgia | 30308 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Southwest CARE Center | Santa Fe | New Mexico | 87505 | United States |
| North Shore University Hospital | Great Neck | New York | 11021 | United States |
| Concorde Medical Group | New York | New York | 10016 | United States |
| Cornell University Gastroenterology & Hepatology | New York | New York | 10021 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Memphis Gastroenterology Group | Germantown | Tennessee | 38138 | United States |
| The North Texas Research Institute | Arlington | Texas | 76012 | United States |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 39090 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Liver Institute of Virginia, Bon Secours | Newport News | Virginia | 23602 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Virginia Mason Medical Center, Digestive Disease Institute | Seattle | Washington | 98101 | United States |
| Medizinische Universität Graz | Graz | 8036 | Austria |
| LKH Innsbruck | Innsbruck | 6020 | Austria |
| Krankenhaus der Elisabethinen Linz GmbH | Linz | 4020 | Austria |
| AKH der Stadt Wien | Vienna | 1090 | Austria |
| Wilhelminenspital der Stadt Wien | Vienna | 1171 | Austria |
| SGS - Clinical Pharmacology Unit Antwerpen | Antwerp | 2060 | Belgium |
| ULB Erasme | Brussels | 1070 | Belgium |
| UCL Saint Luc | Brussels | 1200 | Belgium |
| UZ Antwerp | Edegem | 2650 | Belgium |
| CHU Sart Tilman | Liège | 4000 | Belgium |
| Heritage Medical Research Clinic | Calgary | Alberta | T2N 4N1 | Canada |
| University of Alberta, Division of Gastroenterology | Edmonton | Alberta | T6G 2C2 | Canada |
| Downtown ID Clinic | Vancouver | British Columbia | V3S 4N9 | Canada |
| Gordon & Leslie Diamond Health Care Centre | Vancouver | British Columbia | V5Z 3P1 | Canada |
| GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| John Buhler Research Centre | Winnipeg | Manitoba | R3E 3P4 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Ottawa Hospital, Division of Infectious Diseases | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| University Hospital Brno | Brno | 625 00 | Czechia |
| Melnik Hospital | Mělník | 276 01 | Czechia |
| University Hospital Plzen | Pilsen | 304 60 | Czechia |
| Klinmed, s.r.o. | Prague | 128 00 | Czechia |
| Institute of Clinic and Experimental Medicine | Prague | 140 21 | Czechia |
| Association of Physicians for Infection Diseases | Ústí nad Labem | 477 01 | Czechia |
| Beaujon Hospital | Clichy | 92110 | France |
| Henri Mondor Hospital | Créteil | 94000 | France |
| Claude Huriez Hospital | Lille | 59000 | France |
| Hotel Dieu Hospital | Lyon | 69002 | France |
| Saint Joseph Hospital | Marseille | 13008 | France |
| Nancy University Hospital Center | Vandœuvre-lès-Nancy | 54500 | France |
| Charite University Medicine | Berlin | 13353 | Germany |
| University Hospital Bonn | Bonn | 53105 | Germany |
| University Hospital Essen | Essen | 45122 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt/M | 60590 | Germany |
| University Hospital Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH | Hamburg | 20099 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| University hospital Heidelberg | Heidelberg | 69120 | Germany |
| University Hospital Leipzig | Leipzig | 04103 | Germany |
| Johannes Gutenberg University Hospital | Mainz | 55131 | Germany |
| Ludwig-Maximilians-University Munich | München | 81377 | Germany |
| Epatologia, Azienda Ospedaliero "Spedali Civili" | Brescia | 25123 | Italy |
| U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Medicina Generale - Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone | Palermo | 90127 | Italy |
| Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria | Parma | 43100 | Italy |
| Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista | Torino | 10126 | Italy |
| Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny | Bialystok | 15-540 | Poland |
| Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny | Bydgoszcz | 85-030 | Poland |
| Szpital Specjalistyczny w Chorzowie | Chorzów | 41-500 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia | Czeladź | 41-250 | Poland |
| Wojewodzki Szpital Zespolony w Kielcach | Kielce | 25-736 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi | Lodz | 91-347 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie | Lublin | 20-081 | Poland |
| Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby | Radom | 26-610 | Poland |
| Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie | Szczecin | 71-455 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny | Warsaw | 01-201 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X | Warsaw | 01-201 | Poland |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie | Warsaw | 02-507 | Poland |
| EMC Instytut Medyczny S.A. | Wroclaw | 50-220 | Poland |
| Hospital Universitari Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospital Clínico Universitario San Cecilio | Granada | 18012 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Ntra. Sra. de Valme | Seville | 41014 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| North Manchester General Hospital | Greater Manchester | M8 5RB | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP UK | United Kingdom |
| Barts and The London Hospital | London | E1 2AT | United Kingdom |
| University College London Hospital | London | NW1 2BU | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Chelsea and Westminster Hospital | London | SW109NH | United Kingdom |
| Institute of Cellular Medicine (Hepatology) | Newcastle upon Tyne | NE24HH | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| ID | Term |
|---|---|
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C571890 | tegobuvir |
| C571665 | GS-9256 |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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