A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
NCT ID: NCT03426618
Last Updated: 2019-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1 participants
OBSERVATIONAL
2018-01-12
2019-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Pediatric participants with Hepatitis B Virus (HBV)
All participants who received at least 1 dose of Baraclude.
Non-interventional
Non-interventional
Interventions
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Non-interventional
Non-interventional
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with a contraindication for the use of Baraclude as described in the locally approved prescribing information
2 Years
16 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Seoul, , South Korea
Countries
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Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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AI463-514
Identifier Type: -
Identifier Source: org_study_id
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