Chronic Genotype 1a or 1b HCV Infection Clinical Trial
Official title:
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 (Protocol No. GS US 248 0132)
| Verified date | November 2013 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 163 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult subjects 18 and older with chronic HCV infection - Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis - Monoinfection with HCV genotype 1a or 1b - Interferon ineligible or intolerant - Body mass index (BMI) between 18 and 40 kg/m2 - Use of highly effective contraception methods if female of childbearing potential or sexually active male - Screening laboratory values within defined thresholds - Has not been exposed to any investigational drug or device within 30 days of the Screening visit - Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments Exclusion Criteria: - Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental) - Decompensated liver disease or cirrhosis - Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype - History of difficulty with blood collection and/or poor venous access - Pregnant or nursing female or male with pregnant female partner - Chronic liver disease of a non-HCV etiology - Suspicion of hepatocellular carcinoma - Clinically-relevant drug abuse |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Calgary | Calgary | Alberta |
| Canada | University of Alberta | Edmonton | Alberta |
| Canada | University Of Alberta Hospital | Edmonton | Alberta |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | Hospital Saint-Luc DU CHUM | Montreal | Quebec |
| Canada | The Ottawa Hospital | Ottawa | Ontario |
| Canada | Toronto General Hospital, University Health Network | Toronto | Ontario |
| Canada | Toronto General Hospital, University Health Network | Toronto | Ontario |
| Canada | Toronto Western Hospital | Toronto | Ontario |
| Canada | GIRI GI Research Institute | Vancouver | British Columbia |
| Canada | Gordon & Leslie Diamond Health Care Centre | Vancouver | British Columbia |
| Canada | University of British Columbia | Vancouver | British Columbia |
| Canada | University of Manitoba | Winnipeg | Manitoba |
| Puerto Rico | Clinical Research Puerto Rico Inc | San Juan | |
| United States | The North Texas Research Institute | Arlington | Texas |
| United States | Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina |
| United States | University of Colorado | Aurora | Colorado |
| United States | California Liver Institute | Beverly Hills | California |
| United States | Beth Israel Deconess Medical Center | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | SCTI Research Foundation Liver Center | Coronado | California |
| United States | Inova Fairfax Hospital Center for Liver Diseases | Falls Church | Virginia |
| United States | The University of Texas Medical Branch | Galveston | Texas |
| United States | Gastro One | Germantown | Tennessee |
| United States | The University of Texas Health Sciences Center at Houston | Houston | Texas |
| United States | Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Scripps Clinic | La Jolla | California |
| United States | University of California, San Diego | La Jolla | California |
| United States | Kaiser Permanente Medical Center | Los Angeles | California |
| United States | Lightsource Medical | Los Angeles | California |
| United States | Johns Hopkins University | Lutherville | Maryland |
| United States | Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia |
| United States | University of Miami, Center for Liver Diseases | Miami | Florida |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Saint Michael's Medical Center | Newark | New Jersey |
| United States | Bon Secours St. Mary's Hospital of Richmond, Inc. | Newport News | Virginia |
| United States | Digestive and Liver Disease Specialists | Norfolk | Virginia |
| United States | Henry Ford Health System | Novi | Michigan |
| United States | Orlando Immunology Center (ACH) | Orlando | Florida |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University Gastroenterology | Providence | Rhode Island |
| United States | Alamo Medical Research | San Antonio | Texas |
| United States | Kaiser Permanente | San Diego | California |
| United States | Medical Associates Research Group, Inc. | San Diego | California |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | The Research Institute | Springfield | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Canada, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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, ?z, AUCtau and T ½ | predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose | No |