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: 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
B: Arm Label: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Other: Placebo | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Arm Label: Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: DRUG; Name: Pegylated Interferon Alfa 2a; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
C: Arm Label: Placebo 12 Weeks (GT2/3); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to match SOF, Drug: Placebo to match RBV | Arm Label: SOF 12 Weeks (GT2/3); Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV | Arm Label: SOF 24 Weeks (GT3); Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV | Intervention Type: DRUG; Name: SOF; Assigned to Arm(s): SOF 12 Weeks (GT2/3), SOF 24 Weeks (GT3) | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): SOF 12 Weeks (GT2/3), SOF 24 Weeks (GT3) | Intervention Type: DRUG; Name: Placebo to match SOF; Assigned to Arm(s): Placebo 12 Weeks (GT2/3) | Intervention Type: DRUG; Name: Placebo to match RBV; Assigned to Arm(s): Placebo 12 Weeks (GT2/3)
D: Arm Label: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Drug: Placebo | Arm Label: Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Drug: Telaprevir | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Drug: Telaprevir | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week; Type: EXPERIMENTAL; Interventions: Drug: Pegylated Interferon Alfa 2a, Drug: Telaprevir | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Intervention Type: DRUG; Name: Pegylated Interferon Alfa 2a; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week

Answer: A