Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects
Brief Summary: The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undetectable\] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.


Options:
A: Percentage of Participants Achieving SVR12 (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 16)
B: The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72) (Week 72)
C: Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (12 weeks after the last actual dose of study drug)
D: GSK2336805 safety parameters : adverse events (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: telemetry (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: absolute values and changes over time of hematology, clinical chemistry, urinalysis (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: vital signs (blood pressure, heart rate) (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: electrocardiogram (ECG) parameters (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve over the dosing interval AUC(0-tau)) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: maximum observed concentration (Cmax) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: time to maximum observed concentration (tmax) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: observed concentration at 24h post-dose (C24) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: terminal half-life (t1/2) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: lag time (tlag) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: apparent clearance (CL/F) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following repeat dose administration:AUC(0-tau) (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: Pre-dose (trough) concentration at the end of the dosing interval Ctau (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: Cmax (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: tmax (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: t1/2, (Day 7 and day 14); GSK2336805 PK parameters following repeat dose administration: CL/F (Day 7 and Day 14); GSK2336805 PK parameters following single dose in HCV infected subjects: AUC(0-infinity) or AUC(0 - tau) (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: Cmax (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: C24 (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: tmax (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: tlag (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: CL/F (for 48 hours); HCV Ribonucleic acid (RNA) viral load reduction from baseline during the 24hr and post-dosing following a single dose of GSK2336805 in HCV subjects (at baseline, 24 hours, and for 16 days); HCV RNA change from baseline to nadir (maximum change) in HCV subjects (baseline, and for 16 days); Time course of HCV viral load at baseline, after dosing with GSK2336805, and for greater than or equal to 2 weeks after GSK2336805 dosing (Part 3) (baseline and up to 16 days)

Answer: B