NCT03426618CompletedNot Applicable
A Real-World Observational Study for the Safety and Efficacy of Baraclude (Entecavir) in Korean Pediatric (Aged 2-16 Years) Patients With Chronic Hepatitis B
Bristol-Myers Squibb1 site in 1 country1 target enrollmentStarted: January 12, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Number of Adverse Events (AEs)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of Adverse Events (AEs)
Time Frame: Up to 52 weeks
Secondary Outcomes
- Liver stiffness(Baseline and Week 48 of treatment)
- 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)
- Participants who achieved a virologic response(Up to 48 weeks)
- 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)
- 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)
- Number of participants who had HBsAg loss at week 48(Week 48)
- Number of participants with virologic Relapse in participants(Up to 48 weeks)
- Number of participants with normalization of serum ALT at week 24(Baseline to week 24)
Investigators
Study Sites (1)
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