Last updated: 11/03/2018 08:30:53

HEPSERA Post Marketing SurveillanceHEPSERA PMS

GSK study ID
105711
See study documents
Clinicaltrials.gov ID
NCT01329419
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2010-16-02
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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