HEPSERA Post Marketing Surveillance
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B
Intervention: adefovir dipivoxil (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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
Clinical Details
Official title: A Post-marketing Surveillance to Monitor the Safety of HEPSERA(Adefovir Dipivoxil 10mg) Adminstered in Korean Subjects According to the Prescribing Information
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Number of Participants With an Adverse Event
Secondary outcome: Number of Participants With a Serious Adverse EventNumber of Participants With the Indicated Unexpected Adverse Events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients administrated adefovir dipivoxil at the site
Exclusion Criteria:
- Patients administrated adefovir dipivoxil before center initiated date
Locations and Contacts
Additional Information
Starting date: August 2004
Last updated: March 10, 2011
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