Genotype 1 Hepatitis C Virus Infection MedDRA version: 14.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent. 2. Male or female, aged from 18 to 70 years old, inclusive. 3. Chronic HCV infection for at least 6 months prior to Baseline (Day 1) 4. Subjects must have a liver biopsy performed = 2 years prior to Screening indicating the absence of cirrhosis. 5. Monoinfection with HCV GT 1a or 1b. 6. HCV treatment naïve Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Pregnant female or male with pregnant female partner. 2. Poorly-controlled diabetes mellitus 3. History of clinically significant hemoglobinopathy 4. History of clinically significant retinal disease 5. History of invasive malignancy diagnosed or treated within 5 years 6. Untreated or significant psychiatric illnesses 7. Co-infection with HBV or HIV 12. Known cirrhosis 13. Chronic liver disease of a non-HCV etiology 14. History of solid organ transplantation 15. Suspicion of hepatocellular carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA < LLoQ 24 weeks post-treatment) of 30 mg or 90 mg GS-5885 when given with GS-9451, tegobuvir and RBV for 12 or 24 weeks 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;Secondary Objective: 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 To evaluate the antiviral efficacy (as defined by SVR) of the addition of pegylated interferon (PEG) for 24 weeks to GS-5885, GS-9451 and RBV in subjects who experience viral breakthrough on treatment (Rescue Therapy Substudy) 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 To characterize viral dynamics and steady state pharmacokinetics of GS-5885, GS-9451, and tegobuvir when co-administered with RBV;Primary end point(s): The primary efficacy endpoint is SVR in all randomized and treated subjects, defined as HCV RNA < LLoQ at 24 weeks post-treatment.;Timepoint(s) of evaluation of this end point: 24 weeks post treament | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints include: HCV RNA < LLoQ at Weeks 2, 4, 12 and 24, and SVR in each treatment arm with 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; proportion of subjects with breakthrough on therapy, relapse, and ALT normalization.;Timepoint(s) of evaluation of this end point: Weeks 2, 4, 12 and 24 | — |
Countries
France, Germany, United States
Contacts
Public ContactMedical Monitor
Gilead Sciences Inc
Outcome results
None listed