NCT03426618

Brief Summary

This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2 and less than 16 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 12, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

February 2, 2018

Last Update Submit

May 31, 2019

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events (AEs)

    Up to 52 weeks

Secondary Outcomes (13)

  • Participants who achieved a virologic response

    Up to 48 weeks

  • Mean log reduction in hepititis B virus DNA

    Baseline to Weeks 12, 24, and 48

  • Liver stiffness

    Baseline and Week 48 of treatment

  • Number of participants with resistance to Baraclude

    Up to 52 weeks

  • Number of participants with virologic relapse in participants

    Up to 48 weeks

  • +8 more secondary outcomes

Study Arms (1)

Pediatric participants with Hepatitis B Virus (HBV)

All participants who received at least 1 dose of Baraclude.

Other: Non-interventional

Interventions

Non-interventionalOTHER

Non-interventional

Pediatric participants with Hepatitis B Virus (HBV)

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participants will be enrolled with chronic hepatitis B virus (CHB)between the ages of 2 and less than 16 years and who will begin treatment with Baraclude.

You may qualify if:

  • Signed informed consent
  • to \< 16 years of age
  • Patients with chronic hepatitis B infection, eligible for treatment with Baraclude as indicated in the locally approved prescribing information

You may not qualify if:

  • Off-label use of the approved label in Baraclude pediatric indication
  • Patients with a contraindication for the use of Baraclude as described in the locally approved prescribing information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 8, 2018

Study Start

January 12, 2018

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

June 3, 2019

Record last verified: 2019-05

Locations

KR(1)