HEPSERA Post Marketing Surveillance

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4393 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2010-02-28

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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adefovir dipivoxil

Patients administrated adefovir at the site

adefovir dipivoxil

Intervention Type DRUG

Basically there is no treatment allocation. Subjects who would be administered of adefovir at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Interventions

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adefovir dipivoxil

Basically there is no treatment allocation. Subjects who would be administered of adefovir at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Intervention Type DRUG