HEPSERA Post Marketing Surveillance
HEPSERA PMS
A Post-marketing Surveillance to Monitor the Safety of HEPSERA(Adefovir Dipivoxil 10mg) Adminstered in Korean Subjects According to the Prescribing Information
1 other identifier
observational
4,393
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2004
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
April 5, 2011
CompletedResults Posted
Study results publicly available
April 5, 2011
CompletedJuly 5, 2017
June 1, 2017
5.5 years
March 10, 2011
March 10, 2011
June 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With an Adverse Event
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.
12 weeks
Secondary Outcomes (2)
Number of Participants With a Serious Adverse Event
12 weeks
Number of Participants With the Indicated Unexpected Adverse Events
12 weeks
Study Arms (1)
adefovir dipivoxil
Patients administrated adefovir at the site
Interventions
Basically there is no treatment allocation. Subjects who would be administered of adefovir at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
Eligibility Criteria
Patients administrated adefovir dipivoxil at the site
You may qualify if:
- Patients administrated adefovir dipivoxil at the site
You may not qualify if:
- Patients administrated adefovir dipivoxil before center initiated date
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2011
First Posted
April 5, 2011
Study Start
August 1, 2004
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
July 5, 2017
Results First Posted
April 5, 2011
Record last verified: 2017-06