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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


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 Event

Number 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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