HEPSERA Post Marketing Surveillance (HEPSERA PMS)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hepatitis B

Treatments: Drug: adefovir dipivoxil

Study type: Observational

Funder types: Industry

Identifiers

NCT01329419

105711

Details and patient eligibility

About

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information

Full description

This study is a post-marketing surveillance to monitor safety and efficacy of adefovir dipivoxil and identify SAEs, adverse drug reactions (ADRs), and unexpected AEs not described as precautions or warnings and to identify possible factors that have an effect on the AEs and to assess effectiveness of adefovir dipivoxil in real clinical practices after marketing. The subjects are patients prescribed for adefovir dipivoxil by the investigators at the sites based on prescription information in normal clinical practices.

Enrollment: 4,393 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients administrated adefovir dipivoxil at the site

Exclusion criteria

• Patients administrated adefovir dipivoxil before center initiated date

Trial design

4,393 participants in 1 patient group

adefovir dipivoxil

Description:

Patients administrated adefovir at the site

Treatment:

Drug: adefovir dipivoxil