Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Open-label Study in Japan to Investigate the Efficacy, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment naïve, Genotype 1, Chronic Hepatitis C Subjects
Brief Summary: The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never received treatment for their hepatitis C infection.


Options:
A: Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4 (Day 1 (Baseline) and Week 4); The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During the Study (Weeks 4, 12, 24 or 48, and EOT (up to Week 24 or 48)); The Percentage of Participants With a Decrease of Greater Than or Equal to 2 log10 IU/mL From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Through the Post-treatment Follow-up Period (Days 1 (4 hr), 1 (8 hr), 3, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24,28, 36, 42, 48, 52, 60, 72, and EOT (up to Week 24 or 48)); The Percentage of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Undetectable or Below the Limit of Quantification (<1.2 log10 IU/mL Detectable) During Treatment and During Post Treatment Follow-up (Week 4, 12, 24, 36, 48, EOT (up to Week 24 or 48), and Week 60 and 72); The Number of Participants With Viral Breakthrough (Up to EOT (up to Week 24 or 48)); The Percentage of Participants With Viral Relapse (Week 36 or 60); Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period (Baseline, Week 4, 12, 24, 48, EOT (up to Week 24 or 48), and Weeks 60 and 72); The Number of Participants With Alanine Aminotransaminase (ALT) Values Within the Normal Range at the End-of-treatment (EOT) (Day 1, Weeks 24, 48, and EOT (up to Weeks 24 or 48)); The Percentage of Participants With Sustained Virologic Response (SVR) (SVR4 (up to Week 28 or Week 52), SVR12 (up to Weeks 36 or 60), and SVR24 (up to Weeks 48 or 72)); Predose Plasma Concentrations (C0h) of TMC435 (Sparse Blood Sampling) (Weeks 4, 12, and 24); Predose Plasma Concentrations (C0h) of TMC435 (Intensive Blood Sampling) (Weeks 4 to 6); The Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24) for TMC435 (within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment); Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435 (within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment); The Number of Participants Who Met Virologic Stopping/Continuation Rules and Completed All Study Medications (Week 24)
B: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
C: Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) (At follow-up Week 12)
D: Safety and tolerability: Adverse events, ECG, laboratory parameters (approximately 3 years); Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2 (Days 3-9); Antiviral activity: HCV RNA (COBAS Taqman HCV Test) (from baseline to Day 28)

Answer: A