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

Bristol-Myers Squibb1 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis B

Interventions

Non-interventionalOTHER

Non-interventional

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Adverse Events (AEs)

Time frame: Up to 52 weeks

Secondary Outcomes

Participants who achieved a virologic response

Measured by reduction in hepatitis B virus DNA to \<300 copies/mL

Time frame: Up to 48 weeks

Mean log reduction in hepititis B virus DNA

Time frame: Baseline to Weeks 12, 24, and 48

Liver stiffness

Time frame: Baseline and Week 48 of treatment

Number of participants with resistance to Baraclude

Time frame: Up to 52 weeks

Number of participants with virologic relapse in participants

Viral load of less than or equal to 300 copies/mL

Time frame: Up to 48 weeks

Number of participants with virologic Relapse in participants

Viral load greater than 10,000 copies/mL

Time frame: Up to 48 weeks

Number of participants who were HBeAg seroconverted at Week 48

Time frame: Week 48

Number of participants who had HBeAg loss at week 48

Time frame: Week 48

Number of participants who were HBsAg seroconverted at Week 48

Time frame: Week 48

Data from ClinicalTrials.gov

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