Hepatitis B
Conditions
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.
Interventions
OTHERNon-interventional
Non-interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events (AEs) | Up to 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with resistance to Baraclude | Up to 52 weeks | — |
| 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 | — |
| Liver stiffness | Baseline and Week 48 of treatment | — |
| Number of participants with virologic Relapse in participants | Up to 48 weeks | Viral load greater than 10,000 copies/mL |
| Number of participants who were HBeAg seroconverted at Week 48 | Week 48 | — |
| 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 HBsAg seroconverted at Week 48 | Week 48 | — |
| Number of participants who had HBsAg loss 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 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 |
| 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 |
| Number of participants who had HBeAg loss at week 48 | Week 48 | — |
Countries
South Korea
Outcome results
None listed