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

NCT03642340 | Unknown

• 1 other identifier: ID-BSB-401
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3000

You may qualify if:

• The patient diagnosed with chronic hepatitis B.
• The patient who is first prescribed and administered Besivo.

You may not qualify if:

• 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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ildong Ildong

  PV

  STUDY DIRECTOR

Central Study Contacts

Ildong Ildong

CONTACT

82-2-526-3295; eunbi@ildong.com

Ildong Ildong

CONTACT

82-2-526-3392; kimsh@ildong.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: May 15, 2017
• Primary Completion: May 14, 2023
• Study Completion: August 15, 2023
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

KR (1)