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: Arm 1 (Control Arm); Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo, Biological: Peginterferon alfa-2a, Drug: Ribavirin | Arm Label: Arm 2 (Boceprevir Arm); Type: EXPERIMENTAL; Interventions: Drug: Boceprevir, Biological: Peginterferon alfa-2a, Drug: Ribavirin | Intervention Type: DRUG; Name: Boceprevir; Assigned to Arm(s): Arm 2 (Boceprevir Arm) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm 1 (Control Arm) | Intervention Type: BIOLOGICAL; Name: Peginterferon alfa-2a; Assigned to Arm(s): Arm 1 (Control Arm), Arm 2 (Boceprevir Arm) | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Arm 1 (Control Arm), Arm 2 (Boceprevir Arm)
B: 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
C: Arm Label: GT1 HCV 10-mg Elbasvir (Panel A); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GTI HCV 50-g Elbasvir (Panel B); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT1 HCV 5-mg Elbavir (Panel C); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT1 HCV 200-mg Elbasvir (Panel D); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT3 HCV 10-mg Elbasvir (Panel E); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT3 HCV 50-mg Elbasvir (Panel F); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT3 HCV 100-mg Elbasvir (Panel G); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT3 HCV 200-mg Elbasvir (Panel H); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT1a HCV 10-mg Elbasvir (Panel I); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Arm Label: GT1a HCV 50-mg Elbasvir (Panel J); Type: EXPERIMENTAL; Interventions: Drug: Elbasvir, Drug: Placebo | Intervention Type: DRUG; Name: Elbasvir; Assigned to Arm(s): GT1 HCV 10-mg Elbasvir (Panel A), GT1 HCV 200-mg Elbasvir (Panel D), GT1 HCV 5-mg Elbavir (Panel C), GT1a HCV 10-mg Elbasvir (Panel I), GT1a HCV 50-mg Elbasvir (Panel J), GT3 HCV 10-mg Elbasvir (Panel E), GT3 HCV 100-mg Elbasvir (Panel G), GT3 HCV 200-mg Elbasvir (Panel H), GT3 HCV 50-mg Elbasvir (Panel F), GTI HCV 50-g Elbasvir (Panel B) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): GT1 HCV 10-mg Elbasvir (Panel A), GT1 HCV 200-mg Elbasvir (Panel D), GT1 HCV 5-mg Elbavir (Panel C), GT1a HCV 10-mg Elbasvir (Panel I), GT1a HCV 50-mg Elbasvir (Panel J), GT3 HCV 10-mg Elbasvir (Panel E), GT3 HCV 100-mg Elbasvir (Panel G), GT3 HCV 200-mg Elbasvir (Panel H), GT3 HCV 50-mg Elbasvir (Panel F), GTI HCV 50-g Elbasvir (Panel B)
D: Arm Label: Placebo+PEG2b+RBV, x 44 weeks; Type: PLACEBO_COMPARATOR; Interventions: Biological: Pegylated interferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908), Drug: Boceprevir placebo | Arm Label: Boceprevir+PEG2b+RBV, Response Guided Therapy; Type: EXPERIMENTAL; Interventions: Drug: Boceprevir (SCH 503034), Biological: Pegylated interferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908), Drug: Boceprevir placebo | Arm Label: Boceprevir+PEG2b+RBV, x 44 weeks; Type: EXPERIMENTAL; Interventions: Drug: Boceprevir (SCH 503034), Biological: Pegylated interferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908) | Intervention Type: DRUG; Name: Boceprevir (SCH 503034); Assigned to Arm(s): Boceprevir+PEG2b+RBV, Response Guided Therapy, Boceprevir+PEG2b+RBV, x 44 weeks | Intervention Type: BIOLOGICAL; Name: Pegylated interferon alfa-2b (SCH 54031); Assigned to Arm(s): Boceprevir+PEG2b+RBV, Response Guided Therapy, Boceprevir+PEG2b+RBV, x 44 weeks, Placebo+PEG2b+RBV, x 44 weeks | Intervention Type: DRUG; Name: Ribavirin (SCH 18908); Assigned to Arm(s): Boceprevir+PEG2b+RBV, Response Guided Therapy, Boceprevir+PEG2b+RBV, x 44 weeks, Placebo+PEG2b+RBV, x 44 weeks | Intervention Type: DRUG; Name: Boceprevir placebo; Assigned to Arm(s): Boceprevir+PEG2b+RBV, Response Guided Therapy, Placebo+PEG2b+RBV, x 44 weeks

Answer: B