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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
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
Secondary ID [1] 0 0
2017-003338-94
Secondary ID [2] 0 0
AI444-423
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Chronic Hepatitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
Timepoint [1] 0 0
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Primary outcome [2] 0 0
Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
Timepoint [2] 0 0
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Primary outcome [3] 0 0
Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
Timepoint [3] 0 0
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Primary outcome [4] 0 0
Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
Timepoint [4] 0 0
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Primary outcome [5] 0 0
Apparent Total Body Clearance (CLT/F) for Daclatasvir
Timepoint [5] 0 0
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 [1] 0 0
Number of Participants Experiencing Adverse Events
Timepoint [1] 0 0
From first dose to last dose (12 weeks)
Secondary outcome [2] 0 0
Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
Timepoint [2] 0 0
From the day after first dose to last dose (approximately 12 weeks)
Secondary outcome [3] 0 0
Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
Timepoint [3] 0 0
From day after last dose to end of follow-up period (up to approximately 96 weeks)
Secondary outcome [4] 0 0
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
Timepoint [4] 0 0
12 weeks after last dose

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
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/09/2020
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03487848