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This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks |
|
| Arm 2 | Active Comparator | GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks |
|
| Arm 3 | Active Comparator | GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5885 tablet | Drug | GS-5885 tablet, 90 mg, QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study. | Through 24 weeks of off-treatment follow-up |
| Antiviral Activity | To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA < lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. | Through 24 weeks of off-treatment follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Dynamics | To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. | Through 10 days of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McNally, PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Liver Institute | Beverly Hills | California | 90211 | United States | ||
| SCTI Research Foundation Liver Center |
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| GS-9451 tablet |
| Drug |
GS-9451 tablet, 200 mg QD |
|
| tegobuvir capsule | Drug | tegobuvir capsule, 30 mg BID |
|
| ribavirin tablet | Drug | ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
|
| placebo matching ribavirin tablet | Drug | placebo matching ribavirin tablet, BID |
|
| placebo matching tegobuvir capsule | Device | placebo matching tegobuvir capsule, BID |
|
| Composite (or Profile) of Pharmacokinetics | To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½ | predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| Coronado |
| California |
| 92118 |
| United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| University of California, San Diego | La Jolla | California | 92161 | United States |
| Kaiser Permanente Medical Center | Los Angeles | California | 90027 | United States |
| Lightsource Medical | Los Angeles | California | 90036 | United States |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States |
| Kaiser Permanente | San Diego | California | 92154 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Miami, Center for Liver Diseases | Miami | Florida | 33136 | United States |
| Orlando Immunology Center (ACH) | Orlando | Florida | 32803-1851 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deconess Medical Center | Boston | Massachusetts | 02215 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Henry Ford Health System | Novi | Michigan | 48377 | United States |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| The North Texas Research Institute | Arlington | Texas | 76012 | United States |
| The University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| The University of Texas Health Sciences Center at Houston | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Inova Fairfax Hospital Center for Liver Diseases | Falls Church | Virginia | 22042 | United States |
| Bon Secours St. Mary's Hospital of Richmond, Inc. | Newport News | Virginia | 23602 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| University Of Alberta Hospital | Edmonton | Alberta | T6G 2C8 | Canada |
| University of Alberta | Edmonton | Alberta | T6G 2X8 | Canada |
| Gordon & Leslie Diamond Health Care Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
| University of British Columbia | Vancouver | British Columbia | V6Z 2C9 | Canada |
| GIRI GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| University of Manitoba | Winnipeg | Manitoba | R3E 3P4 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto General Hospital, University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto General Hospital, University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T2S8 | Canada |
| Hospital Saint-Luc DU CHUM | Montreal | Quebec | H2X3J4 | Canada |
| Clinical Research Puerto Rico Inc | San Juan | 00909-1711 | Puerto Rico |
| 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 |
|---|---|
| C586541 | ledipasvir |
| C573362 | GS-9451 |
| C571890 | tegobuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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