Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection
Brief Summary: The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)
B: Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a (Up to 5 days); Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5 (Up to 5 days); Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event (Up to 5 days)
C: Percentage of Participants With Virologic Response at Week 12 (End of treatment (EOT) (up to Week 48))
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: C