GS-5885
Drugtablet, 30 mg QD
NCT Number: NCT01356160
This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Herston, Queensland, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tablet, 30 mg QD
tablet, 200 mg QD
(solution for injection) 180 µg/week
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Placebo to match GS-9451 QD
Time frame: Through 24 weeks post-treatment
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
Time frame: Through 24 weeks post-treatment
The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.
Time frame: Through Day 10 on study
HCV RNA levels, pharmacokinetics and viral sequencing
Time frame: 12 or 24 weeks
Plasma samples will be collected and stored at each visit for possible resistance analysis.
Time frame: Through 48 weeks of treatment
Plasma concentrations of the study drug over time will be summarized using descriptive statistics.
Gilead Sciences
Industry
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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