N/A Completed N=4,393

HEPSERA Post Marketing Surveillance

Hepatitis B

Source: ClinicalTrials.gov NCT01329419 ↗

Enrolled (actual)

4,393

Serious AEs

0.8%

Results posted

Apr 2011

Primary outcomePrimary: Number of Participants With an Adverse Event — 74 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With an Adverse Event	74	—
SECONDARY Number of Participants With a Serious Adverse Event	32	—
SECONDARY Number of Participants With the Indicated Unexpected Adverse Events	5; 4; 2; 7; 2; 1	—

Eligibility Criteria

Inclusion Criteria

Patients administrated adefovir dipivoxil at the site

Exclusion Criteria

Patients administrated adefovir dipivoxil before center initiated date

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01329419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.