Efficacy and safety of simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients: multi-center, open label, randomized, controlled study

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2014
INTERVENTION: Simeprevir/pegylated‐interferon/ribavirin combination therapy with Vitamin D3 for 24weeks Simeprevir/pegylated‐interferon/ribavirin combination therapy without Vitamin D3 for 24weeks CONDITION: Chronic hepatitis C PRIMARY OUTCOME: Sustained virological response rate SECONDARY OUTCOME: Safety and HCV‐RNA dynamics INCLUSION CRITERIA: Patient with HCV RNA high viral load (>5.0 log IU/mL) as determined by quantitative analysis with real‐time polymerase chain reaction (PCR), infection with HCV genotype 1b, IL28B (rs8099917) minor genotype (TG or GG), white blood cell (WBC) count > 2,000/mm3, neutrophil count > 1,500/mm3, platelet count > 80,000/mm3, and hemoglobin concentration > 11.0 g/dl.
Epistemonikos ID: ced0c6d65ed7009fd9e7a7f44b46b368438d4164
First added on: Aug 22, 2024