Status:
COMPLETED
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B
Eligibility:
All Genders
2-16 years
Brief Summary
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 13 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03426618
Start Date
January 12 2018
End Date
March 13 2019
Last Update
June 3 2019
Active Locations (1)
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1
Local Institution
Seoul, South Korea