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The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks. |
|
| Arm 2 | Active Comparator | GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5885 | Drug | tablet, 30 mg QD |
| |
| Tegobuvir |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR) | 24 weeks of off-treatment follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | To evaluate the safety and tolerability of 30 mg or 90 mg GS-5885 when given with GS-9451, Tegobuvir and RBV for 12 or 24 weeks. Safety endpoints will be analyzed by the number and percent of subjects with events or abnormalities for categorical values or 8-number summary (n, mean, standard deviation, median, Q1, Q3, minimum, maximum) for continuous data by treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benedetta Massetto, MD, PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Gastroenterology Associates, P.C. | Birmingham | Alabama | 35209 | United States | ||
| Digestive Health Specialists of the Southeast |
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| Drug |
capsule, 30 mg BID |
|
| GS-9451 | Drug | tablet, 200 mg QD |
|
| ribavirin tablet | Drug | (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
|
| GS-5885 | Drug | tablet, 90 mg QD |
|
| through 24 weeks of off-treatment follow-up |
| HCV RNA < Lower Limit Of Quantification | To evaluate the antiviral efficacy at Weeks 1, 2, 4, 12 and 24, as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse. | Weeks 1, 2, 4, 12 and 24 |
| Rescue Therapy Substudy SVR | To evaluate the antiviral efficacy (as defined by SVR) of the addition of pegylated interferon (PEG) for 24 weeks to GS-5885, GS-9451, tegobuvir and RBV in subjects who experience viral breakthrough on treatment. | 24 Weeks |
| Emergence of viral resistance | To evaluate the emergence of viral resistance during treatment with GS-9451, Tegobuvir and RBV when given with 30 mg or 90 mg GS-5885 for 12 or 24 weeks. | 12 or 24 weeks |
| Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV | HCV RNA levels, pharmacokinetics and viral sequencing | Through Week 2 of therapy |
| Pharmacokinetics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV | Pharmacokinetics (Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau, and T½) will be listed and summarized for GS-5885, GS-9451 and Tegobuvir using descriptive statistics (e.g., sample size, arithmetic mean, geometric mean, % coefficient of variation, standard deviation, median, minimum, and maximum). Plasma concentrations of the study drug over time will be summarized using descriptive statistics | Through Week 2 of therapy |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States |
| Southern California Liver Centers | Coronado | California | 92118 | United States |
| UCSF Fresno Medical Education Program (MEP) | Fresno | California | 93721 | United States |
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
| University of California San Diego | San Diego | California | 92103 | United States |
| Kaiser Permanente | San Diego | California | 92154 | United States |
| UCSF | San Francisco | California | 94143 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
| Bach and Godofsky Infectious Diseases | Bradenton | Florida | 34209 | United States |
| University of Florida - Gainesville | Gainesville | Florida | 32610 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| University of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Gastrointestinal Specialists of Georgia PC | Marietta | Georgia | 30060 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Private Practice | Opelousas | Louisiana | 70570 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Gastrointestinal Associates, PA | Jackson | Mississippi | 39202 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7584 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Memphis Gastroenterology Group | Germantown | Tennessee | 38138 | United States |
| Columbia Medical Group, The Frist Clinic | Nashville | Tennessee | 37203 | United States |
| Nashville Gastrointestinal Specialists, Inc | Nashville | Tennessee | 37211 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Research Specialists of Texas | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Lifetree Clinical Research, LC | Salt Lake City | Utah | 84106 | United States |
| Inova Fairfax Hospital - Center for Liver Diseases | Falls Church | Virginia | 22042 | United States |
| Liver Institute of Virginia, Bon Secours Health System | Newport News | Virginia | 23602 | United States |
| Fundacion de Investigacion de Diego | San Juan | 00927 | Puerto Rico |
| 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 |
|---|---|
| C586541 | ledipasvir |
| C571890 | tegobuvir |
| C573362 | GS-9451 |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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