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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
N/A
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
Terminated
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
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to
children with chronic hepatitis C infection
Trial website
https://clinicaltrials.gov/ct2/show/NCT03487848
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03487848