GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01384383
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 248
- Males and females 18-70 years of age
- Chronic HCV infection
- Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
- Monoinfection with HCV genotype 1a or 1b
- HCV RNA > 10^4 IU/mL at Screening
- IL28B CC genotype
- HCV treatment naïve
- Candidate for PEG/RBV therapy
- Body mass index (BMI) between 18 and 36 kg/m2
- Creatinine clearance >= 50 mL/min
- Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline
- Exceed defined thresholds for key laboratory parameters at Screening
- 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 skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
- Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
- Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 GS-5885 Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks. Arm 1 GS-9451 Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks. Arm 1 RBV Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks. Arm 1 PEG Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks. Arm 2 RBV Response-Guided Therapy with PEG and RBV for 24 weeks. Arm 2 PEG Response-Guided Therapy with PEG and RBV for 24 weeks.
- Primary Outcome Measures
Name Time Method Sustained virologic response (SVR) 30 , 36 or 48 weeks 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.
- Secondary Outcome Measures
Name Time Method Safety and tolerability of therapy Up to 48 weeks Safety and tolerability of the therapy is measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events.
Virologic response Weeks 2, 4, 6, 8, 10, and 12 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
Compare SVR Weeks 30 and 36 Compare SVR following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 weeks versus 12 weeks.
Viral resistance Up to 96 Weeks Characterize viral resistance to GS-5885 and GS-9451 when administered in combination with PEG/RBV
Trial Locations
- Locations (54)
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
North Shore University Hospital
🇺🇸Great Neck, New York, United States
Research Specialists of Texas
🇺🇸Houston, Texas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Royal Brisbane Hospital Research Foundation
🇦🇺Herston, Queensland, Australia
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Western Hospital
🇦🇺Footscray, Victoria, Australia
St. Vincent's Hospital, Sydney Ltd.
🇦🇺Fitzroy, Victoria, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Box Hill Hospital
🇦🇺Melbourne, Victoria, Australia
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
San Jose Gastroenterology
🇺🇸San Jose, California, United States
Research and Education, Inc.
🇺🇸San Diego, California, United States
South Denver Gastroenterology
🇺🇸Englewood, Colorado, United States
Asheville Gastroenterology Associates, P.A.
🇺🇸Asheville, North Carolina, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Liver Institute of Virginia, Bon Secours Health System
🇺🇸Newport News, Virginia, United States
St. George Hospital
🇦🇺Kogarah, New South Wales, Australia
Weill Cornell College of Medicine
🇺🇸New York, New York, United States
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
University of Calgary
🇨🇦Calgary, Alberta, Canada
Westchester Medical Center
🇺🇸Yonkers, New York, United States
Metropolitan Liver Diseases Center
🇺🇸Fairfax, Virginia, United States
Saint Vincents Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Austin Health, Department of Hepatology
🇦🇺Heidelberg, Victoria, Australia
Auckland Hospital
🇳🇿Aukland, New Zealand
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia
London Health Sciences
🇨🇦London, Ontario, Canada
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
V.A. Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Stanford, California, United States
Greenslopes Private Hospital
🇦🇺Woolloongabba, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
GIRI GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
University of Manitoba, John Buhler Research Centre
🇨🇦Winnipeg, Manitoba, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Waikato Hospital
🇳🇿Hamilton, New Zealand
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
The North Texas Research Institute
🇺🇸Arlington, Texas, United States
Commonwealth Clinical Studies, LLC
🇺🇸Brockton, Massachusetts, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Utah Pediatric Pulmonology
🇺🇸Salt Lake City, Utah, United States
LAIR Centre
🇨🇦Vancouver, British Columbia, Canada
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia