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

NCT03642340 — Unknown, 3000 participants, IlDong Pharmaceutical Co Ltd

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03642340
StatusUnknown
Study typeObservational
Enrollment3000 (Estimated)
SponsorIlDong Pharmaceutical Co Ltd (Industry)
ConditionsChronic Hepatitis b
Datesstart 2017-05-15, primary completion 2023-05-14 (estimated), completion 2023-08-15 (estimated), first posted 2018-08-22, last updated 2018-08-31
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Hepatitis b

-Summary

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

Expand all sections  ·  Collapse all

+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.

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 20 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Severance HospitalSeoulSouth KoreaRecruiting

+Investigators