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: 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
B: Arm Label: Arm 1. PEG +RBV for 48 Wks (Part I); Type: ACTIVE_COMPARATOR; Interventions: Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 2. PEG + RBV + BOC for 28 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 4. PEG +RBV + BOC for 48 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 6. PEG + RBV + BOC for 48 Wks (Part II); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin (low-dose) | Arm Label: Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Intervention Type: DRUG; Name: boceprevir (SCH 503034); Assigned to Arm(s): Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: peginterferon-alfa 2b (PegIntron); Assigned to Arm(s): Arm 1. PEG +RBV for 48 Wks (Part I), Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: ribavirin; Assigned to Arm(s): Arm 1. PEG +RBV for 48 Wks (Part I), Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: ribavirin (low-dose); Assigned to Arm(s): Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
C: 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
D: Arm Label: Cohort 1; Type: EXPERIMENTAL; Interventions: Drug: ANA598 200 mg bid or placebo | Arm Label: Cohort 2; Type: EXPERIMENTAL; Interventions: Drug: ANA598 400 mg bid or placebo | Arm Label: Cohort 3; Type: EXPERIMENTAL; Interventions: Drug: ANA598 800 mg bid or placebo | Intervention Type: DRUG; Name: ANA598 200 mg bid or placebo; Assigned to Arm(s): Cohort 1 | Intervention Type: DRUG; Name: ANA598 400 mg bid or placebo; Assigned to Arm(s): Cohort 2 | Intervention Type: DRUG; Name: ANA598 800 mg bid or placebo; Assigned to Arm(s): Cohort 3

Answer: C