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

Hepatitis C Clinical Trial

Official title:

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children From 3 to Less Than 18 Years of Age With GT-1 to -6 Chronic Hepatitis C (CHC) Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03487848
• Other study ID #: AI444-423
• Secondary ID: 2017-003338-94
• Status: Terminated
• Phase: Phase 2
• Start date: June 25, 2018
• Est. completion date: September 17, 2020

Study information

• Verified date: April 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 17, 2020
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Related Conditions & MeSH terms

• Chronic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Daclatasvir
Specified dose on specified days for specified duration
• Sofosbuvir
Specified dose on specified days for specified duration

Locations

Country	Name	City	State
Australia	Local Institution	Melbourne	Victoria
Spain	Local Institution	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Number of Participants Experiencing Adverse Events	This outcome describes the number of participants experiencing different types of any grade adverse events.	From first dose to last dose (12 weeks)
Secondary	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.	From the day after first dose to last dose (approximately 12 weeks)
Secondary	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.	From day after last dose to end of follow-up period (up to approximately 96 weeks)
Secondary	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)	12 weeks after last dose

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls