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

Bristol-Myers Squibb (BMS) logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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