Hepatitis C, Chronic Clinical Trial
Official title:
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared With GS-5885, GS-9451 With Tegobuvir or RBV in Treatment-Experienced Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
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 (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection.
Status | Completed |
Enrollment | 170 |
Est. completion date | July 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age =18 years with chronic HCV infection - Liver biopsy results = 3 years prior to screening indicating the absence of cirrhosis. Alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed - Monoinfection with HCV genotype (GT) 1a or 1b - HCV RNA = 104 IU/mL at screening - Prior treatment and adherence with one course of pegylated interferon alfa and RBV - The subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse. - Body mass index (BMI) 18-40 kg/m2 inclusive - Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia's formula) = 450 msec for males and = 470 msec for females. - Agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at screening and baseline. Exclusion Criteria: - Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up - History of significant cardiac disease - Exceed criteria delineated in Section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (TSH). - Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed. - Current abuse of amphetamines, cocaine, opiates, or alcohol. Methadone use is not allowed, however stable buprenorphine maintenance treatment for = 6 months is permitted. |
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 |
---|---|---|---|
Germany | Charite - Universitatsmedizin Berlin Campus Virchow-Klinikum | Berlin | |
Germany | Leber- and Studienzentrum am Checkpoint | Berlin | |
Germany | Universitätsklinikum Bonn | Bonn | |
Germany | Center for HIV and Hepatogastroenterology | Düsseldorf | |
Germany | Klinikum der Johann Wolfgang Goethe Universitaet | Frankfurt | |
Germany | Medizinische Universitatsklinik | Freiburg | |
Germany | Universitatsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Klinikum der Universität Heidelberg | Heidelberg | |
Germany | Gastroenterologisch-Hepatologisches Zentrum Kiel | Kiel | |
Germany | Universitätsklinikum Leipzig | Leipzig | |
Germany | Johannes Gutenberg University Hospital | Mainz | |
Germany | Klinikum Innenstadt der LMU Munchen | Muenchen | |
Germany | Universitätsklinikum Würzburg - Med Klinik und Poliklinik | Würzburg | |
United States | Advanced Clinical Research Institute, LLC | Anaheim | California |
United States | Mercy Medical Center | Baltimore | Maryland |
United States | California Liver Institute | Beverly Hills | California |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | SCTI Research Foundation Liver Center | Coronado | California |
United States | Southwest Infectious Disease Clinical Research, Inc | Dallas | Texas |
United States | Infectious Disease Specialists of Atlanta | Decatur | Georgia |
United States | Avail Clinical Research, LLC | DeLand | Florida |
United States | 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 | Therapeutic Concepts, PA | Houston | Texas |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of California, San Diego | La Jolla | California |
United States | Lightsource Medical | Los Angeles | California |
United States | Johns Hopkins University | Lutherville | Maryland |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | University of Miami, Center for Liver Diseases | Miami | Florida |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Weill Medical College of Cornell Univeristy | New York | New York |
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 | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University Gastroenterology | Providence | Rhode Island |
United States | University of Utah | Salt Lake City | Utah |
United States | Alamo Medical Research, Ltd. | 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 | San Jose Gastroenterology | San Jose | California |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | University of Arizona | Tucson | Arizona |
United States | Whitman Walker Clinic | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Germany,
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. |
24 weeks | Yes |
Primary | Antiviral Activity | To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA < lower limit of quantitation [LLoQ] 24 weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and RBV compared with GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and RBV in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection | 24 weeks | 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. | 10 days | No |
Secondary | Composite (or Profile) of Pharmacokinetics 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 |
Secondary | Antiviral Efficacy | To evaluate the antiviral efficacy (as defined by SVR) of adding pegylated interferon alfa-2a (PEG) and RBV (Arm 2 only) for 24-48 weeks to the original treatment regimen in subjects who experience viral breakthrough or relapse and enter the Rescue Therapy Substudy | 24-48 weeks | No |
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