Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric participants with Hepatitis B Virus (HBV) | All participants who received at least 1 dose of Baraclude. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Non-interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participants who achieved a virologic response | Measured by reduction in hepatitis B virus DNA to <300 copies/mL | Up to 48 weeks |
| Mean log reduction in hepititis B virus DNA | Baseline to Weeks 12, 24, and 48 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Not provided
Not provided
Participants will be enrolled with chronic hepatitis B virus (CHB)between the ages of 2 and less than 16 years and who will begin treatment with Baraclude.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Seoul | South Korea |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
Not provided
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| Liver stiffness | Baseline and Week 48 of treatment |
| Number of participants with resistance to Baraclude | Up to 52 weeks |
| Number of participants with virologic relapse in participants | Viral load of less than or equal to 300 copies/mL | Up to 48 weeks |
| Number of participants with virologic Relapse in participants | Viral load greater than 10,000 copies/mL | Up to 48 weeks |
| Number of participants who were HBeAg seroconverted at Week 48 | Week 48 |
| Number of participants who had HBeAg loss at week 48 | Week 48 |
| 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 | Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT | Baseline to week 12 |
| Number of participants with normalization of serum ALT at week 24 | Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT | Baseline to week 24 |
| Number of participants with normalization of serum ALT at week 48 | Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT | Baseline to week 48 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |