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This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks. |
|
| Arm 2 | Experimental | Response-Guided Therapy with PEG and RBV for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5885 | Drug | GS-5885 30 mg tablet administered orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR) | Sustained virologic response (SVR, defined as plasma HCV RNA < lower limit of quantification [LLoQ] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects. | 30 , 36 or 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of therapy | Safety and tolerability of the therapy is measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events. | Up to 48 weeks |
| Virologic response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | United States | ||
| Axis Clinical Trials |
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| GS-9451 |
| Drug |
GS-9451 200 mg tablet administered orally once daily |
|
| RBV | Drug | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
| PEG | Drug | Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection |
|
Virologic response at Weeks 2, 4, 6, 8, 10, and 12 (depending on treatment arm) as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse
| Weeks 2, 4, 6, 8, 10, and 12 |
| Compare SVR | Compare SVR following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 weeks versus 12 weeks. | Weeks 30 and 36 |
| Viral resistance | Characterize viral resistance to GS-5885 and GS-9451 when administered in combination with PEG/RBV | Up to 96 Weeks |
| Los Angeles |
| California |
| 90057 |
| United States |
| UCLA Medical Center | Los Angeles | California | 90057 | United States |
| V.A. Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| Research and Education, Inc. | San Diego | California | 92105 | United States |
| San Jose Gastroenterology | San Jose | California | 95116 | United States |
| Stanford University | Stanford | California | 94035 | United States |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| Commonwealth Clinical Studies, LLC | Brockton | Massachusetts | 02302 | United States |
| Impact Clinical Trials | Las Vegas | Nevada | 89106 | United States |
| North Shore University Hospital | Great Neck | New York | 11021 | United States |
| Weill Cornell College of Medicine | New York | New York | 10021 | United States |
| Westchester Medical Center | Yonkers | New York | 10701 | United States |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| The North Texas Research Institute | Arlington | Texas | 76012 | United States |
| Research Specialists of Texas | Houston | Texas | 77030 | United States |
| University of Utah Pediatric Pulmonology | Salt Lake City | Utah | 84143 | United States |
| Metropolitan Liver Diseases Center | Fairfax | Virginia | 22031 | United States |
| Liver Institute of Virginia, Bon Secours Health System | Newport News | Virginia | 23602 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | 2137 | Australia |
| Saint Vincents Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 2747 | Australia |
| St. George Hospital | Kogarah | New South Wales | NSW 2217 | Australia |
| Liverpool Hospital | Sydney | New South Wales | 1871 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane Hospital Research Foundation | Herston | Queensland | 4029 | Australia |
| Greenslopes Private Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| St. Vincent's Hospital, Sydney Ltd. | Fitzroy | Victoria | 3065 | Australia |
| Western Hospital | Footscray | Victoria | VIC 3011 | Australia |
| Austin Health, Department of Hepatology | Heidelberg | Victoria | 3081 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Monash Medical Centre | Melbourne | Victoria | 3004 | Australia |
| Box Hill Hospital | Melbourne | Victoria | 3128 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Fremantle Hospital | Fremantle | Western Australia | 6160 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| University of Calgary | Calgary | Alberta | T2N4N1 | Canada |
| University of Alberta | Edmonton | Alberta | T6G 2C8 | Canada |
| LAIR Centre | Vancouver | British Columbia | V5Z 1H2 | Canada |
| GIRI GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| University of Manitoba, John Buhler Research Centre | Winnipeg | Manitoba | R3E 3P4 | Canada |
| London Health Sciences | London | Ontario | N6A5A5 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| Auckland Hospital | Aukland | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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 |
|---|---|
| C586541 | ledipasvir |
| C573362 | GS-9451 |
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