Last updated: 11/03/2018 08:30:53
HEPSERA Post Marketing SurveillanceHEPSERA PMS
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A post-marketing surveillance to monitor the safety of HEPSERA(adefovir dipivoxil 10mg) adminstered in Korean subjects according to the prescribing information
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with an adverse event
Timeframe: 12 weeks
Secondary outcomes:
Number of participants with a serious adverse event
Timeframe: 12 weeks
Number of participants with the indicated unexpected adverse events
Timeframe: 12 weeks
Interventions:
Drug: adefovir dipivoxil
Enrollment:
4393
Observational study model:
Cohort
Primary completion date:
2010-16-02
Time perspective:
Prospective
Clinical publications:
Keun Young Shin1, Hong-Mi Choi, Shin-Young Oh, Joon Hyung Kim, Yil-Seob Lee, Young Oh Kweon. Post-Marketing Surveillance for the Safety and Effectiveness of Adefovir in Patients with Chronic Hepatitis B. [J Korean Soc Clin Pharmacol Ther]. 2011;19(2):180-191.
Medical condition
Hepatitis B
Product
adefovir
Collaborators
Not applicable
Study date(s)
August 2004 to February 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Patients administrated adefovir dipivoxil at the site
- Patients administrated adefovir dipivoxil before center initiated date
Inclusion and exclusion criteria
Inclusion criteria:
- Patients administrated adefovir dipivoxil at the site
Exclusion criteria:
- Patients administrated adefovir dipivoxil before center initiated date
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-16-02
Actual study completion date
2010-16-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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