Back to resultsEvaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
Primary Purpose
Hepatitis C, Chronic Hepatitis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Daclatasvir
Sofosbuvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
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
Sites / Locations
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Daclatasvir with Sofosbuvir
Arm Description
Specified dose on specified days for specified duration
Outcomes
Primary Outcome Measures
Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
Apparent Total Body Clearance (CLT/F) for Daclatasvir
Secondary Outcome Measures
Number of Participants Experiencing Adverse Events
This outcome describes the number of participants experiencing different types of any grade adverse events.
Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
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.
Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
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.
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03487848
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Business objectives have changed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
September 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daclatasvir with Sofosbuvir
Arm Type
Experimental
Arm Description
Specified dose on specified days for specified duration
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Intervention Description
Specified dose on specified days for specified duration
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Intervention Description
Specified dose on specified days for specified duration
Primary Outcome Measure Information:
Title
Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
Time Frame
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Title
Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
Time Frame
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Title
Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
Time Frame
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Title
Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
Time Frame
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Title
Apparent Total Body Clearance (CLT/F) for Daclatasvir
Time Frame
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 Measure Information:
Title
Number of Participants Experiencing Adverse Events
Description
This outcome describes the number of participants experiencing different types of any grade adverse events.
Time Frame
From first dose to last dose (12 weeks)
Title
Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
Description
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.
Time Frame
From the day after first dose to last dose (approximately 12 weeks)
Title
Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
Description
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.
Time Frame
From day after last dose to end of follow-up period (up to approximately 96 weeks)
Title
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
Description
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)
Time Frame
12 weeks after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
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