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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03487848




Registration number
NCT03487848
Ethics application status
Date submitted
20/03/2018
Date registered
4/04/2018
Date last updated
15/04/2020

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
Maximum observed concentration (Cmax) derived from plasma concentration for Daclatasvir
Timepoint [1] 0 0
10 days
Primary outcome [2] 0 0
Time taken to reach maximum concentration (Tmax) derived from plasma concentration for Daclatasvir
Timepoint [2] 0 0
10 days
Primary outcome [3] 0 0
Area under the concentration-time curve in one dosing interval [AUC(TAU)] derived from plasma concentration for Daclatasvir
Timepoint [3] 0 0
10 days
Primary outcome [4] 0 0
Apparent total body clearance (CLT/F) derived from plasma concentration for Daclatasvir
Timepoint [4] 0 0
10 days
Primary outcome [5] 0 0
Trough observed concentration (Cmin) derived from plasma concentration for Daclatasvir
Timepoint [5] 0 0
10 days
Secondary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [2] 0 0
120 weeks
Secondary outcome [3] 0 0
Number of participants with AEs leading to discontinuation of study therapy
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Number of participants with laboratory abnormalities in blood
Timepoint [4] 0 0
120 weeks
Secondary outcome [5] 0 0
Number of participants with laboratory abnormalities in blood serum
Timepoint [5] 0 0
120 weeks
Secondary outcome [6] 0 0
Number of participants with HCV RNA less than lower limit of quantification
Timepoint [6] 0 0
24 weeks

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Germany
State/province [1] 0 0
Wuppertal
Country [2] 0 0
Poland
State/province [2] 0 0
Krakow
Country [3] 0 0
Poland
State/province [3] 0 0
Lodz
Country [4] 0 0
Romania
State/province [4] 0 0
Bucuresti
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona
Country [6] 0 0
Spain
State/province [6] 0 0
Madrid
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei

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/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
Other publications