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

Completed

• Conditions: Hepatitis B
• Interventions: Other: Non-interventional

• Registration Number: NCT03426618
• Lead Sponsor: Bristol-Myers Squibb

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 who are between the ages of 2 and less than 16 years.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-12
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-08
• Primary Completion: 2019-03-13
• Study Completion: 2019-03-13
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-31
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric participants with Hepatitis B Virus (HBV)	Non-interventional	All participants who received at least 1 dose of Baraclude.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs)	Up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants who had HBeAg loss at week 48	Week 48
Number of participants with normalization of serum ALT at week 48	Baseline to week 48	Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Participants who achieved a virologic response	Up to 48 weeks	Measured by reduction in hepatitis B virus DNA to \<300 copies/mL
Mean log reduction in hepititis B virus DNA	Baseline to Weeks 12, 24, and 48
Number of participants who were HBsAg seroconverted at Week 48	Week 48
Number of participants with resistance to Baraclude	Up to 52 weeks
Number of participants with virologic relapse in participants	Up to 48 weeks	Viral load of less than or equal to 300 copies/mL
Number of participants who were HBeAg seroconverted at Week 48	Week 48
Number of participants with normalization of serum ALT at week 12	Baseline to week 12	Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Number of participants with virologic Relapse in participants	Up to 48 weeks	Viral load greater than 10,000 copies/mL
Number of participants who had HBsAg loss at week 48	Week 48
Number of participants with normalization of serum ALT at week 24	Baseline to week 24	Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Liver stiffness	Baseline and Week 48 of treatment

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of