A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo

• Conditions: Chronic Hepatitis b

• Registration Number: NCT03642340
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

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.

Study Timeline

• Study Start: 2017-05-15
• Status Verified: 2018-08
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31
• Primary Completion: 2023-05-14
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of