NCT03487848

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2018

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2020

Completed
7 months until next milestone

Results Posted

Study results publicly available

April 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

March 20, 2018

Results QC Date

March 12, 2021

Last Update Submit

April 16, 2021

Conditions

Hepatitis CChronic Hepatitis

Outcome Measures

Primary Outcomes (5)

  • Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir

    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

    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

    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

    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

    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 (4)

  • Number of Participants Experiencing Adverse Events

    From first dose to last dose (12 weeks)

  • Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis

    From the day after first dose to last dose (approximately 12 weeks)

  • Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis

    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

    12 weeks after last dose

Study Arms (1)

Daclatasvir with Sofosbuvir

EXPERIMENTAL

Specified dose on specified days for specified duration

Drug: DaclatasvirDrug: Sofosbuvir

Interventions

DaclatasvirDRUG

Specified dose on specified days for specified duration

Daclatasvir with Sofosbuvir
SofosbuvirDRUG

Specified dose on specified days for specified duration

Daclatasvir with Sofosbuvir

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Melbourne, Victoria, 3052, Australia

Location

Local Institution

Barcelona, 08950, Spain

Location

Related Links

MeSH Terms

Conditions

Hepatitis CHepatitis, Chronic

Interventions

daclatasvirSofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Limitations and Caveats

This study was terminated early by sponsor for reasons unrelated to safety.

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com
Please email

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 4, 2018

Study Start

June 25, 2018

Primary Completion

October 18, 2018

Study Completion

September 17, 2020

Last Updated

April 20, 2021

Results First Posted

April 20, 2021

Record last verified: 2021-04

Locations

ES(1)AU(1)