Please select the arm or intervention descriptions that belong 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 PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy
Brief Summary: The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).


Options:
A: Arm Label: TMC435 100 mg 12 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 100 mg 24 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 100 mg 48 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 12 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 24 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 48 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: Placebo 48 Wks + PR48; Type: PLACEBO_COMPARATOR; Interventions: Drug: TMC435, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48 | Intervention Type: DRUG; Name: Peg-IFN-alfa-2a (P); Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48 | Intervention Type: DRUG; Name: Ribavirin (R); Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48
B: Arm Label: Group 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Daclatasvir, Drug: Placebo | Arm Label: Group 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Daclatasvir, Drug: Placebo | Arm Label: Group 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Daclatasvir, Drug: Placebo | Arm Label: Group 4; Type: ACTIVE_COMPARATOR; Interventions: Drug: Daclatasvir, Drug: Placebo | Arm Label: Group 5; Type: ACTIVE_COMPARATOR; Interventions: Drug: Daclatasvir, Drug: Placebo | Arm Label: Group 6; Type: ACTIVE_COMPARATOR; Interventions: Drug: Daclatasvir, Drug: Placebo | Intervention Type: DRUG; Name: Daclatasvir; Assigned to Arm(s): Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
C: Arm Label: PegIFN/RBV; Type: ACTIVE_COMPARATOR; Interventions: Drug: PegIFN/RBV | Arm Label: BI 201335 for 12 or 24 weeks; Type: EXPERIMENTAL; Interventions: Drug: PegIFN/RBV, Drug: BI 201335 | Arm Label: Placebo and PegIFN/RBV; Type: ACTIVE_COMPARATOR; Interventions: Drug: PegIFN/RBV, Drug: Placebo | Intervention Type: DRUG; Name: PegIFN/RBV; Assigned to Arm(s): BI 201335 for 12 or 24 weeks, PegIFN/RBV, Placebo and PegIFN/RBV | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): BI 201335 for 12 or 24 weeks | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): BI 201335 for 12 or 24 weeks | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and PegIFN/RBV
D: Arm Label: Phase 2a: Arm 1; Type: EXPERIMENTAL; Interventions: Drug: BMS-650032, Drug: Peginterferon Alfa-2a, Drug: Ribavirin | Arm Label: Phase 2a: Arm 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon Alfa-2a, Drug: Ribavirin | Arm Label: Phase 2b: Arm 1; Type: EXPERIMENTAL; Interventions: Drug: BMS-650032, Drug: Placebo, Drug: Peginterferon Alfa-2a, Drug: Ribavirin | Arm Label: Phase 2b: Arm 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon Alfa-2a, Drug: Ribavirin | Intervention Type: DRUG; Name: BMS-650032; Assigned to Arm(s): Phase 2a: Arm 1 | Intervention Type: DRUG; Name: BMS-650032; Assigned to Arm(s): Phase 2b: Arm 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Phase 2a: Arm 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Phase 2b: Arm 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Phase 2b: Arm 2 | Intervention Type: DRUG; Name: Peginterferon Alfa-2a; Assigned to Arm(s): Phase 2a: Arm 1, Phase 2a: Arm 2, Phase 2b: Arm 2 | Intervention Type: DRUG; Name: Peginterferon Alfa-2a; Assigned to Arm(s): Phase 2b: Arm 1 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Phase 2a: Arm 1, Phase 2a: Arm 2, Phase 2b: Arm 2 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Phase 2b: Arm 1

Answer: A