Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
Brief Summary: The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.

The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.

A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.

This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.

Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)


Options:
A: Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: BI 201335, Drug: BI 207127 | Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: BI 207127, Drug: BI 201335, Drug: Ribavirin | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: BI 207127, Drug: BI 201335, Drug: Ribavirin | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: BI 207127, Drug: Ribavirin, Drug: BI 201335 | Arm Label: 5; Type: EXPERIMENTAL; Interventions: Drug: BI 201335, Drug: BI 207127, Drug: Ribavirin | Arm Label: 6; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: BI 201335, Drug: BI 207217 | Arm Label: 7; Type: EXPERIMENTAL; Interventions: Drug: BI 207127, Drug: BI 201335 | Arm Label: 8; Type: EXPERIMENTAL; Interventions: Drug: BI 207127, Drug: Ribavirin, Drug: BI 201335 | Arm Label: 9; Type: EXPERIMENTAL; Interventions: Drug: BI 207127, Drug: BI 201335, Drug: Ribavirin | Arm Label: 10; Type: EXPERIMENTAL; Interventions: Drug: BI 201335, Drug: BI 207127, Drug: Ribavirin | Arm Label: 11; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: BI 207127, Drug: BI 201335 | Arm Label: 12; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: BI 201335, Drug: BI 207127 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 4 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 5 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 11 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 4 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 6 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 5 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 9 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 11 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 10 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 5 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 7 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 6 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 11 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 12 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 12 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 7 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 12 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 9 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 8 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 8 | Intervention Type: DRUG; Name: BI 207217; Assigned to Arm(s): 6 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 8 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 10 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: BI 207127; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): 4 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 9 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 10
B: Arm Label: Cohort A; Type: EXPERIMENTAL; Interventions: Drug: RO5024048 | Arm Label: Cohort B; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort C; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort D; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort E; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort F; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort G; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Intervention Type: DRUG; Name: RO5024048; Assigned to Arm(s): Cohort A | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort B | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort C | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort D | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort E | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort F, Cohort G
C: Arm Label: ABT-450/r/ABT-267 and ABT-333, plus RBV; Type: EXPERIMENTAL; Interventions: Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin | Arm Label: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV; Type: EXPERIMENTAL; Interventions: Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin, Drug: Placebo for ABT-450/r/ABT-267, Drug: Placebo for ABT-333, Drug: Placebo for ribavirin | Intervention Type: DRUG; Name: ABT-450/r/ABT-267, ABT-333; Assigned to Arm(s): ABT-450/r/ABT-267 and ABT-333, plus RBV, Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): ABT-450/r/ABT-267 and ABT-333, plus RBV, Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ABT-450/r/ABT-267; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ABT-333; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ribavirin; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
D: Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Copegus, Drug: Pegasys, Drug: Placebo | Arm Label: Part 1: RO5190591 300mg po; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir) | Arm Label: Part 1: RO5190591 600mg po; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir) | Arm Label: Part 1: RO5190591 900mg po; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir) | Arm Label: Part 2: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Copegus, Drug: Pegasys, Drug: Placebo | Arm Label: Part 2: RO5190591 300mg po; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir) | Intervention Type: DRUG; Name: Copegus; Assigned to Arm(s): Part 1: Placebo, Part 1: RO5190591 300mg po, Part 1: RO5190591 600mg po, Part 1: RO5190591 900mg po, Part 2: Placebo, Part 2: RO5190591 300mg po | Intervention Type: DRUG; Name: Pegasys; Assigned to Arm(s): Part 1: Placebo, Part 1: RO5190591 300mg po, Part 1: RO5190591 600mg po, Part 1: RO5190591 900mg po, Part 2: Placebo, Part 2: RO5190591 300mg po | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part 1: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part 2: Placebo | Intervention Type: DRUG; Name: RO5190591 (Danoprevir); Assigned to Arm(s): Part 1: RO5190591 300mg po | Intervention Type: DRUG; Name: RO5190591 (Danoprevir); Assigned to Arm(s): Part 1: RO5190591 600mg po | Intervention Type: DRUG; Name: RO5190591 (Danoprevir); Assigned to Arm(s): Part 1: RO5190591 900mg po | Intervention Type: DRUG; Name: RO5190591 (Danoprevir); Assigned to Arm(s): Part 2: RO5190591 300mg po

Answer: A