A Phase 2 interventional study of GS-5885 tablet and GS-9451 tablet in Chronic Genotype 1a or 1b HCV Infection, sponsored by Gilead Sciences. Completed at 50 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-20.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 163 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
Drug: GS-5885 tablet · Drug: GS-9451 tablet · Drug: tegobuvir capsule · Drug: ribavirin tablet
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
Drug: GS-5885 tablet · Drug: GS-9451 tablet · Drug: tegobuvir capsule · Drug: placebo matching ribavirin tablet
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
Drug: GS-5885 tablet · Drug: GS-9451 tablet · Drug: ribavirin tablet · Device: placebo matching tegobuvir capsule
GS-5885 tablet, 90 mg, QD
GS-9451 tablet, 200 mg QD
tegobuvir capsule, 30 mg BID
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
placebo matching ribavirin tablet, BID
placebo matching tegobuvir capsule, BID
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.
Time frame: Through 24 weeks of off-treatment follow-up
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.
Time frame: Through 24 weeks of off-treatment follow-up
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.
Time frame: Through 10 days of therapy
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, λz, AUCtau and T ½
Time frame: predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Gilead Sciences