Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
Brief Summary: This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.


Options:
A: Arm Label: Arm 1: Null or Partial Responder to P/R (ASV + DCV); Type: EXPERIMENTAL; Interventions: Drug: Asunaprevir (ASV), Drug: Daclatasvir (DCV) | Arm Label: Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV); Type: EXPERIMENTAL; Interventions: Drug: Asunaprevir (ASV), Drug: Daclatasvir (DCV) | Arm Label: Arm 3: Treatment naive (ASV + DCV); Type: EXPERIMENTAL; Interventions: Drug: Asunaprevir (ASV), Drug: Daclatasvir (DCV), Drug: Pegylated-interferon alfa 2a (PegIFN), Drug: Ribavirin (RBV) | Arm Label: Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week; Type: EXPERIMENTAL; Interventions: Drug: Asunaprevir (ASV), Drug: Daclatasvir (DCV), Drug: Pegylated-interferon alfa 2a (PegIFN), Drug: Ribavirin (RBV) | Intervention Type: DRUG; Name: Asunaprevir (ASV); Assigned to Arm(s): Arm 1: Null or Partial Responder to P/R (ASV + DCV), Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV), Arm 3: Treatment naive (ASV + DCV), Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week | Intervention Type: DRUG; Name: Daclatasvir (DCV); Assigned to Arm(s): Arm 1: Null or Partial Responder to P/R (ASV + DCV), Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV), Arm 3: Treatment naive (ASV + DCV), Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week | Intervention Type: DRUG; Name: Pegylated-interferon alfa 2a (PegIFN); Assigned to Arm(s): Arm 3: Treatment naive (ASV + DCV), Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week | Intervention Type: DRUG; Name: Ribavirin (RBV); Assigned to Arm(s): Arm 3: Treatment naive (ASV + DCV), Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week
B: Arm Label: TMC435 25 mg (Cohort 1/Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 75mg (Cohort 1/Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 1/Panel A and B); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 2, Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 2/Panel A and B); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 75 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 150 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 4/Panel C); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 5/Panel D); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C) | Intervention Type: DRUG; Name: Peginterferon (PegIFNα-2a); Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C), TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B) | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C), TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B)
C: 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
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: D