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

IlDong Pharmaceutical

Status: Unknown

Conditions: Chronic Hepatitis b

Study type: Observational

Funder types: Industry

Identifiers

NCT03642340

ID-BSB-401

Details and patient eligibility

About

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

Full description

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

Enrollment: 3,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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