A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B

May 31, 2019 updated by: Bristol-Myers Squibb

A Real-World Observational Study for the Safety and Efficacy of Baraclude (Entecavir) in Korean Pediatric (Aged 2-16 Years) Patients With Chronic Hepatitis B

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

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

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

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric participants with Hepatitis B Virus (HBV)
All participants who received at least 1 dose of Baraclude.
Other: Non-interventional
Non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events (AEs)
Time Frame: Up to 52 weeks
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants who achieved a virologic response
Time Frame: Up to 48 weeks
Measured by reduction in hepatitis B virus DNA to <300 copies/mL
Up to 48 weeks
Mean log reduction in hepititis B virus DNA
Time Frame: Baseline to Weeks 12, 24, and 48
Baseline to Weeks 12, 24, and 48
Liver stiffness
Time Frame: Baseline and Week 48 of treatment
Baseline and Week 48 of treatment
Number of participants with resistance to Baraclude
Time Frame: Up to 52 weeks
Up to 52 weeks
Number of participants with virologic relapse in participants
Time Frame: Up to 48 weeks
Viral load of less than or equal to 300 copies/mL
Up to 48 weeks
Number of participants with virologic Relapse in participants
Time Frame: Up to 48 weeks
Viral load greater than 10,000 copies/mL
Up to 48 weeks
Number of participants who were HBeAg seroconverted at Week 48
Time Frame: Week 48
Week 48
Number of participants who had HBeAg loss at week 48
Time Frame: Week 48
Week 48
Number of participants who were HBsAg seroconverted at Week 48
Time Frame: Week 48
Week 48
Number of participants who had HBsAg loss at week 48
Time Frame: Week 48
Week 48
Number of participants with normalization of serum ALT at week 12
Time Frame: Baseline to week 12
Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Baseline to week 12
Number of participants with normalization of serum ALT at week 24
Time Frame: Baseline to week 24
Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Baseline to week 24
Number of participants with normalization of serum ALT at week 48
Time Frame: Baseline to week 48
Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Baseline to week 48

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)

January 12, 2018

Primary Completion (Actual)

March 13, 2019

Study Completion (Actual)

March 13, 2019

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI463-514

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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