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

Chronic Hepatitis b Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642340
• Other study ID #: ID-BSB-401
• Status: Recruiting
• Start date: May 15, 2017
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2018
• Source: IlDong Pharmaceutical Co Ltd
• Contact: Ildong Ildong
• Phone: 82-2-526-3295
• Email: eunbi[@]ildong.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.

Description:

This post-marketing surveillance required by Korea MFDS regulation. The objectives of this study are to monitor adverse events and effectiveness of Besivo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 15, 2023
• Est. primary completion date: May 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse event after this drug administration in general medical practice.	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.	48weeks
Primary	Incidence of serious adverse event after this drug administration in general medical practice.	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.	48 weeks