Last updated: 11/07/2018 04:39:27

Drug Use Investigation for HEPSERA (adefovir) Tablet

GSK study ID
112299
See study documents
Clinicaltrials.gov ID
NCT01863589
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: Drug Use Investigation for HEPSERA (adefovir) Tablet
Trial description: This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir tablets.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse drug reactions

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Adefovir tablets
    • Enrollment:
    436
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Atsuko Ishida,Terufumi Hara,Pascal Yoshida.A Drug Use Investigation to Monitor the Improvement Effect of Hepatic Function and Safety of Adefovir (Hepsera®) Tablets in Patients with Hepatitis B Virus-related Liver Disease (Final Results).J Clin Therapeut Med.2014;30(5):415-428
    Medical condition
    Hepatitis B
    Product
    adefovir, lamivudine
    Collaborators
    Not applicable
    Study date(s)
    February 2005 to September 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Subjects with chronic hepatitis B or hepatic cirrhosis B
    • Subjects treated with adefovir tablets
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with chronic hepatitis B or hepatic cirrhosis B
    • Subjects treated with adefovir tablets
    Exclusion criteria:
    • None

    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
    Not applicable
    Actual study completion date
    2012-28-09

    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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