Conditions: Hepatitis C Virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 230
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

Detailed description:

Arms:
arm 1: Participants with hepatitis C virus genotype 1b received daclatasvir, 30 mg, once daily with or without food + simeprevir, 150 mg, once daily with a meal for 12 weeks arm 2: Participants with hepatitis C virus genotype 1b received daclatasvir, 30 mg, once daily with or without food + simeprivir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \>=75 kg received 1200 mg per day) for 12 weeks. arm 3: Participants with hepatitis C virus genotype 1a received daclatasvir, 30 mg, once daily with or without food + simeprevir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \>=75 kg received 1200 mg per day) for 12 weeks. arm 4: Participants with hepatitis C virus genotype 1a received daclatasvir, 30 mg, once daily with or without food + simeprivir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \>=75 kg received 1200 mg per day.

Interventions: intervention 1: Daclatasvir intervention 2: Simeprevir intervention 3: Ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 30 mg, once daily intervention 2: Capsule, oral, 150 mg, once daily intervention 3: Tablets, oral, 500-600 mg, twice daily

Protocol document: