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This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | GS-9451 and Tegobuvir (GS-9190) 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 | Active Comparator | GS-9451 (active) and Tegobuvir (GS-9190) placebo 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 Tegobuvir (GS-9190) and GS-9451 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 |
|---|---|---|---|---|
| Tegobuvir (GS-9190) | Drug | Tegobuvir (GS-9190) capsule, 30 mg BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response | Sustained virologic response (SVR) defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after treatment cessation | 24 weeks of off-treatment follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of therapy | Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events | Through treatment period and 24 weeks of off-treatment follow-up |
| Emergence of viral resistance following initiation of therapy with GS 9190 and GS 9451 |
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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 |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | United States | ||
| Alabama Liver and Digestive Specialists |
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| GS-9451 |
| Drug |
GS-9451 tablet, 200 mg once daily (QD) |
|
| Pegasys® | Biological | peginterferon alfa-2a (solution for injection) 180 µg/week |
|
| Copegus® | Drug | ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
|
| GS-9451 | Drug | GS-9451 tablet, 200 mg QD |
|
| Tegobuvir placebo | Drug | placebo matching Tegobuvir (GS-9190) capsule BID |
|
| Pegasys® | Biological | peginterferon alfa-2a (solution for injection) 180 µg/week |
|
| Copegus® | Drug | ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
|
| Tegobuvir placebo | Drug | placebo matching Tegobuvir (GS-9190) capsule BID |
|
| GS-9451 placebo | Drug | placebo matching GS-9451 tablet QD |
|
| Pegasys® | Biological | peginterferon alfa-2a (solution for injection) 180 µg/week |
|
| Copegus® | Drug | ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet |
|
| Through 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 | Viral dynamics and steady state pharmacokinetics of GS 9190 and GS 9451 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9451 over time | Through Week 4 of therapy |
| Durability of response in subjects who achieve SVR | 36 months following Week 72 |
| Montgomery |
| Alabama |
| 36116 |
| United States |
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
| University of Arizona | Tucson | Arizona | 85724 | United States |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | United States |
| eStudySite | Chula Vista | California | 91911 | United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| eStudySite | La Mesa | California | 91942 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Synergy Clinical Research Center | National City | California | 91950 | United States |
| eStudySite | Oceanside | California | 92056 | United States |
| RESEARCH and EDUCATION, INC | San Diego | California | 92015 | 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 |
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94121 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| South Denver Gastroenterology | Englewood | Colorado | 80110 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Bach and Godofsky Infectious Diseases | Bradenton | Florida | 34209 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Palmetto Research | Hialeah | Florida | 33016 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Florida Hospital | Orlando | Florida | 32804 | United States |
| South Florida Center of Gastroenterology, LLC | Wellington | Florida | 33414 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | United States |
| Emory University, Infectious Disease Clinic | Atlanta | Georgia | 30308 | United States |
| Liver Center of Atlanta | Atlanta | Georgia | 30309 | United States |
| Dekalb Gastroenterology | Decatur | Georgia | 30033 | United States |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| IGRF | Indianapolis | Indiana | 46237 | United States |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Digestive Disease Associates, PA | Baltimore | Maryland | 21229 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Partners in Internal Medicine, P.C. | Worcester | Massachusetts | 01608 | United States |
| Henry Ford Health System-Columbus center | Novi | Michigan | 48377 | United States |
| MN Gastroenterology, P.A. | Plymouth | Minnesota | 55446 | United States |
| Gastrointestinal Associates, PA | Jackson | Mississippi | 39202 | United States |
| Digestive Health Specialists, PA | Tupelo | Mississippi | 38801 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| ID Care 105 | Hillsborough | New Jersey | 08844 | United States |
| Atlantic Research Affiliates, LLC | Morristown | New Jersey | 07960 | United States |
| University of Medicine and Dentistry of New Jersey | Newark | New Jersey | 07103 | United States |
| UNM Health Sciences Center | Albuquerque | New Mexico | 87106 | United States |
| Binghamton Gastroenterology | Binghamton | New York | 13903 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Concorde Medical Group | New York | New York | 10016 | United States |
| NYU Hepatology Associates | 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 |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Consultants for Clinical | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Memphis Gastroenterology Group | Germantown | Tennessee | 38138 | United States |
| James H. Quillen VA Medical Center | Mountain Home | Tennessee | 37684 | United States |
| Columbia Medical Group, The Frist Clinic | Nashville | Tennessee | 37203 | United States |
| The North Texas Research Institute | Arlington | Texas | 76012 | United States |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390-8887 | United States |
| Kelsey Research Foundation | Houston | Texas | 77005 | United States |
| Advanced Liver Therapies | Houston | Texas | 77030 | United States |
| Research Specialists of Texas | Houston | Texas | 77030 | United States |
| Amcare Research Inc. | Houston | Texas | 77090 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Brooke Army Medical Center | San Antonio | Texas | 78234 | 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 |
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53792 | United States |
| Landeskrankenhaus Graz West | Graz | 8020 | Austria |
| 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 |
| Ziekenhuis Netwerk Antwerpen | Antwerp | 2060 | Belgium |
| ULB Erasme | Brussels | 1070 | Belgium |
| UCL Saint Luc | Brussels | 1200 | Belgium |
| UZ Antwerp | Edegem | 2650 | Belgium |
| Centre Hospitalier Universitaire Sart Tilman Liège | Liège | Belgium |
| Beaujon Hospital | Clichy | 92110 | France |
| Henri Mondor Hospital | Créteil | 94010 | France |
| Hôpital de la Croix Rousse | Lyon | 69004 | France |
| Saint Joseph Hospital | Marseille | 13285 | France |
| Hôpital de I´Archet 2, Service Hépatologie | Nice | 06200 | France |
| Centre Hospitalier Régional d'Orléans, Hôpital de la Source | Orléans | 45067 | France |
| Hôpital Cochin | Paris | 75679 | France |
| Groupe Hospitalier du Haut Leveque | Pessac | 33604 | France |
| Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil | Strasbourg | 67091 | France |
| Nancy University Hospital Center | Vandœuvre-lès-Nancy | 54511 | France |
| Charite University Medicine | Berlin | 13353 | Germany |
| Leber- und Studienzentrum am Checkpoint | 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 |
| Asklepios Klinik Sankt Georg | 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 |
| Academisch Medisch Centrum Universiteit Van Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| Radaboud University Nijmegen Medical Centre (UMC St Radboud) | Nijmegen | 6525 GA | Netherlands |
| Erasmus University Medical Center Rotterdam | Rotterdam | 3015 GD | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| 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 Zakład Opieki Zdrowotnej "Pol-SaNa-Med" Sp. z o.o. | Czeladź | 41-250 | Poland |
| Wojewodzki Szpital Zespolony w Kielcach | Kielce | 25-317 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Krakow | 31-531 | 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 Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny | Warsaw | 01-201 | Poland |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie | Warsaw | 02-507 | Poland |
| Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego | Wroclaw | 51-149 | Poland |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP UK | United Kingdom |
| Barts and The London Hospital | London | E1 2AT | United Kingdom |
| Royal Free Hospital | London | NW1 2BU | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| Saint Mary's Hosptial | London | W2 1NY | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| North Manchester General Hospital | Manchester | M8 5RB | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| 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 |
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| ID | Term |
|---|---|
| C571890 | tegobuvir |
| C573362 | GS-9451 |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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