An explosive study on add-on effects of ribavirin in sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
INTERVENTION: RBV add‐on for 12 weeks CONDITION: Patients with chronic HCV infection, who failed to DCV/ASV therapy PRIMARY OUTCOME: To investigate the sustained virologic response (SVR) rate at follow‐up Week 12 SECONDARY OUTCOME: Effects of HCV NS5A/B mutations as viral factors on virologic response; 2) Rate of emergence of drug‐resistant variants; 3) Presence or absence of a reversal of liver fibrosis; 4) Presence or absence of an improvement in AFP levels; 5) Incidence of AEs INCLUSION CRITERIA: Patients (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study. (1) Subjects Patients with a chronic HCV infection and compensated cirrhosis who failed to DCV/ASV combination therapy (2) Inclusion criteria [1] Patients who are 20 years of age or older at the time of informed consent [2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation [3] Patients with a chronic HCV genotype 2 infection and compensated cirrhosis who do not meet any of the following exclusion criteria
Epistemonikos ID: b0365fa66950485a2a5f3cccb7140b928d7b6b8c
First added on: Aug 23, 2024