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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
First received
Last updated
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
Health authority
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

Study Design


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
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