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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Hepatitis B

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03426618

AI463-514

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 1 patient group

Pediatric participants with Hepatitis B Virus (HBV)

Description:

All participants who received at least 1 dose of Baraclude.

Treatment:

Other: Non-interventional