Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection

April 16, 2021 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • Local Institution
  • Spain
      • Barcelona, Spain, 08950
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daclatasvir with Sofosbuvir
Specified dose on specified days for specified duration
Drug: Daclatasvir
Specified dose on specified days for specified duration
Drug: Sofosbuvir
Specified dose on specified days for specified duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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
Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
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
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 Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events
Time Frame: From first dose to last dose (12 weeks)
This outcome describes the number of participants experiencing different types of any grade adverse events.
From first dose to last dose (12 weeks)
Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
Time Frame: From the day after first dose to last dose (approximately 12 weeks)

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.
From the day after first dose to last dose (approximately 12 weeks)
Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
Time Frame: From day after last dose to end of follow-up period (up to approximately 96 weeks)

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.
From day after last dose to end of follow-up period (up to approximately 96 weeks)
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
Time Frame: 12 weeks after last dose

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)
12 weeks after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Actual)

October 18, 2018

Study Completion (Actual)

September 17, 2020

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-423
  • 2017-003338-94 (EudraCT Number)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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