N/A
N=4,393
HEPSERA Post Marketing Surveillance
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT01329419 ↗Enrolled (actual)
4,393
Serious AEs
0.8%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With an Adverse Event — 74 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- adefovir dipivoxil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2010
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 | — |
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
Eligibility Criteria
Inclusion Criteria
- Patients administrated adefovir dipivoxil at the site
Exclusion Criteria
- Patients administrated adefovir dipivoxil before center initiated date
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.