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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis B

Intervention / Treatment
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* Other: Non-interventional


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric participants with Hepatitis B Virus (HBV)<br>All participants who received at least 1 dose of Baraclude. | Other: Non-interventional<br>* Non-interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) |  | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants who achieved a virologic response | Measured by reduction in hepatitis B virus DNA to <300 copies/mL | 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 | Viral load of less than or equal to 300 copies/mL | Up to 48 weeks | 
| Number of participants with virologic Relapse in participants | Viral load greater than 10,000 copies/mL | Up to 48 weeks | 
| Number of participants who were HBeAg seroconverted at Week 48 |  | Week 48 | 
| Number of participants who had HBeAg loss at week 48 |  | Week 48 | 
| Number of participants who were HBsAg seroconverted at Week 48 |  | Week 48 | 
| Number of participants who had HBsAg loss at week 48 |  | Week 48 | 
| Number of participants with normalization of serum ALT at 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 | 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 | Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT | Baseline to week 48 |