Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)
Brief Summary: This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.


Options:
A: Arm Label: Arm A; Type: EXPERIMENTAL; Interventions: Drug: Filibuvir | Arm Label: Arm B; Type: EXPERIMENTAL; Interventions: Drug: Filibuvir | Arm Label: Arm C; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Filibuvir; Assigned to Arm(s): Arm A | Intervention Type: DRUG; Name: Filibuvir; Assigned to Arm(s): Arm B | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Arm C
B: Arm Label: 20mg; Type: EXPERIMENTAL; Interventions: Drug: BI201335 | Arm Label: 48mg; Type: EXPERIMENTAL; Interventions: Drug: BI201335 | Arm Label: 120mg; Type: EXPERIMENTAL; Interventions: Drug: BI201335 | Arm Label: 240mg; Type: EXPERIMENTAL; Interventions: Drug: BI201335 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): 240mg | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): 120mg | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): 48mg | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): 20mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: 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)
D: Arm Label: 24-wk Vaniprevir 600 mg + Peg-IFN/RBV; Type: EXPERIMENTAL; Interventions: Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV) | Arm Label: 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV; Type: EXPERIMENTAL; Interventions: Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV), Drug: Placebo (PBO) | Arm Label: 48-wk Vaniprevir 300 mg + Peg-IFN/RBV; Type: EXPERIMENTAL; Interventions: Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV) | Arm Label: 48-wk Vaniprevir 600 mg + Peg-IFN/RBV; Type: EXPERIMENTAL; Interventions: Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV) | Arm Label: 48-wk PBO + Peg-IFN/RBV; Type: PLACEBO_COMPARATOR; Interventions: Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV), Drug: Placebo (PBO) | Intervention Type: DRUG; Name: Vaniprevir; Assigned to Arm(s): 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Intervention Type: DRUG; Name: Pegylated Interferon (Peg-IFN); Assigned to Arm(s): 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Intervention Type: DRUG; Name: Ribavirin (RBV); Assigned to Arm(s): 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Intervention Type: DRUG; Name: Placebo (PBO); Assigned to Arm(s): 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV

Answer: B