Clinical trial NCT03487848: Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatitis C
Chronic Hepatitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-04
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection


Eligibility criteria: 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

Primary outcomes:
measure: Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
timeFrame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
timeFrame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
measure: Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
timeFrame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
measure: Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
timeFrame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
measure: Apparent Total Body Clearance (CLT/F) for Daclatasvir
timeFrame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Secondary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: From first dose to last dose (12 weeks)
measure: Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
timeFrame: From the day after first dose to last dose (approximately 12 weeks)
measure: Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
timeFrame: From day after last dose to end of follow-up period (up to approximately 96 weeks)
measure: Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
timeFrame: 12 weeks after last dose
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Barcelona
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: