The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Specified dose on specified days for specified duration
Specified dose on specified days for specified duration
Local Institution
Melbourne, Victoria, Australia
Local Institution
Barcelona, Spain
Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
Time frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
Time frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
Time frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
Time frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Apparent Total Body Clearance (CLT/F) for Daclatasvir
Time frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Number of Participants Experiencing Adverse Events
This outcome describes the number of participants experiencing different types of any grade adverse events.
Time frame: From first dose to last dose (12 weeks)
Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
Laboratory tests abnormalities were analyzed in the following categories: * Hematology (hemoglobin, platelets, international normalized ratio (INR), white blood cell count (WBC), lymphocytes (absolute), neutrophils + bands (absolute; ANC)). * Hepatobiliary enzymes (ALT, AST, alkaline phosphatase, total bilirubin, albumin). * Pancreatic enzymes (lipase, creatinine). Tests results were reported by worst toxicity grade (0 to 4) based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2017). Only laboratory abnormalities with a worst toxicity grade 3 or higher in any of the above-mentioned tests, experienced during the on-treatment period, are reported here.
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Time frame: From the day after first dose to last dose (approximately 12 weeks)
Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
Laboratory tests abnormalities were analyzed in the following categories: * Hematology (hemoglobin, platelets, international normalized ratio (INR), white blood cell count (WBC), lymphocytes (absolute), neutrophils + bands (absolute; ANC)). * Hepatobiliary enzymes (ALT, AST, alkaline phosphatase, total bilirubin, albumin). * Pancreatic enzymes (lipase, creatinine). Tests results were reported by worst toxicity grade (0 to 4) based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2017). Only laboratory abnormalities with a worst toxicity grade 3 or higher in any of the above-mentioned tests, experienced during the follow-up period, are reported here.
Time frame: From day after last dose to end of follow-up period (up to approximately 96 weeks)
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
HCV RNA levels were measured by using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0. This assay has a lower limit of quantitation (LLOQ) = 15 IU/mL. The outcome includes both results where Target was Detected (TD) but below LLOQ and results were Target was Not Detected (TND)
Time frame: 12 weeks after last dose