A Post-marketing Surveillance to Monitor the Safety of HEPSERA(Adefovir Dipivoxil 10mg) Adminstered in Korean Subjects According to the Prescribing Information
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 4,393
- Primary Endpoint
- Number of Participants With an Adverse Event
Study Overview
Brief 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
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients administrated adefovir dipivoxil at the site
Exclusion Criteria
- •Patients administrated adefovir dipivoxil before center initiated date
Arms & Interventions
adefovir dipivoxil
Patients administrated adefovir at the site
Intervention: adefovir dipivoxil (Drug)
Outcomes
Primary Outcomes
Number of Participants With an Adverse Event
Time Frame: 12 weeks
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
Secondary Outcomes
- Number of Participants With the Indicated Unexpected Adverse Events(12 weeks)
- Number of Participants With a Serious Adverse Event(12 weeks)