Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection

Phase 2

Terminated

• Conditions: Hepatitis C; Chronic Hepatitis
• Interventions: Drug: Daclatasvir; Drug: Sofosbuvir

• Registration Number: NCT03487848
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-04
• Study Start: 2018-06-25
• Primary Completion: 2018-10-18
• Study Completion: 2020-09-17
• Results First Submitted: 2021-03-12
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-16
• Last Update Submitted: 2021-04-16
• Results First Posted: 2021-04-20
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Participants monoinfected with HCV genotype -1 to -6
• HCV RNA ≥1,000 IU/mL at Screening
• Participants who are HCV-treatment naïve or treatment experienced
• Participants in Cohort 1 must have a body weight ≥ 45kg at Day 1

Exclusion Criteria

• Mixed genotype HCV infections
• Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV
• Evidence of cirrhosis, either compensated or decompensated
• Prior exposure to sofosbuvir and/or NS5A inhibitor

Other protocol defined inclusion/exclusion criteria could apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daclatasvir with Sofosbuvir	Daclatasvir	Specified dose on specified days for specified duration
Daclatasvir with Sofosbuvir	Sofosbuvir	Specified dose on specified days for specified duration

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) for Daclatasvir	Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir	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	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	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	Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12	12 weeks after last dose	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)
Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis	From the day after first dose to last dose (approximately 12 weeks)	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.
Number of Participants Experiencing Adverse Events	From first dose to last dose (12 weeks)	This outcome describes the number of participants experiencing different types of any grade adverse events.
Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis	From day after last dose to end of follow-up period (up to approximately 96 weeks)	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.

Trial Locations

Locations (1)

Local Institution; 🇪🇸 Barcelona, Spain