Chronic Hepatitis b
Conditions
Brief summary
This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.
Detailed description
This post-marketing surveillance required by Korea MFDS regulation. The objectives of this study are to monitor adverse events and effectiveness of Besivo.
Interventions
None listed
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient diagnosed with chronic hepatitis B. * The patient who is first prescribed and administered Besivo.
Exclusion criteria
* The patients who are overreacting to this drug or its components * Medium to severe Renal function disorder * The patient under 19 * The Patient who are taboo with L-Carnitine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse event after this drug administration in general medical practice. | 48weeks | Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. |
| Incidence of serious adverse event after this drug administration in general medical practice. | 48 weeks | Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. |
Countries
South Korea
Contacts
Primary ContactIldong Ildong
Backup ContactIldong Ildong
Outcome results
None listed