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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03487848
Registration number
NCT03487848
Ethics application status
Date submitted
20/03/2018
Date registered
4/04/2018
Date last updated
20/04/2021
Titles & IDs
Public title
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
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Scientific 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
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Secondary ID [1]
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2017-003338-94
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Secondary ID [2]
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AI444-423
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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Chronic Hepatitis
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Daclatasvir
Treatment: Drugs - Sofosbuvir
Experimental: Daclatasvir with Sofosbuvir - Specified dose on specified days for specified duration
Treatment: Drugs: Daclatasvir
Specified dose on specified days for specified duration
Treatment: Drugs: Sofosbuvir
Specified dose on specified days for specified duration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
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Assessment method [1]
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Timepoint [1]
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Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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Primary outcome [2]
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Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
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Assessment method [2]
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Timepoint [2]
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Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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Primary outcome [3]
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Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
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Assessment method [3]
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Timepoint [3]
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Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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Primary outcome [4]
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Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
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Assessment method [4]
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Timepoint [4]
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Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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Primary outcome [5]
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Apparent Total Body Clearance (CLT/F) for Daclatasvir
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Assessment method [5]
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Timepoint [5]
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Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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Secondary outcome [1]
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Number of Participants Experiencing Adverse Events
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Assessment method [1]
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This outcome describes the number of participants experiencing different types of any grade adverse events.
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Timepoint [1]
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From first dose to last dose (12 weeks)
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Secondary outcome [2]
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Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
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Assessment method [2]
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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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Timepoint [2]
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From the day after first dose to last dose (approximately 12 weeks)
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Secondary outcome [3]
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Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
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Assessment method [3]
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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.
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Timepoint [3]
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From day after last dose to end of follow-up period (up to approximately 96 weeks)
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Secondary outcome [4]
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Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
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Assessment method [4]
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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)
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Timepoint [4]
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12 weeks after last dose
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* 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
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Minimum age
12
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/09/2020
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Local Institution - Melbourne
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Recruitment postcode(s) [1]
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3052 - Melbourne
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Recruitment outside Australia
Country [1]
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Spain
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State/province [1]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
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Trial website
https://clinicaltrials.gov/study/NCT03487848
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/48/NCT03487848/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/48/NCT03487848/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03487848
Download to PDF