Last updated: 11/07/2018 04:40:18

Drug Use Investigation for IMURAN (azathioprine) Tablet (hepatic transplantation)

GSK study ID
112305
See study documents
Clinicaltrials.gov ID
NCT01390766
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 IMURAN (azathioprine) Tablet (hepatic transplantation)
Trial description: This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of incidence of adverse events related to azathioprine tablets and serious adverse events

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Azathioprine
    • Enrollment:
    41
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Ichiro Kumegawa, Norikazu Watanabe, Yusuke Inoue, Terufumi Hara, Pascal Yoshida . Drug Use Investigation of Azathioprine (Imuran®) Tablet in Patients undergoing Hepatic Transplantation . J Clin Therapeut Med. 2013;29(3):245-258.
    Medical condition
    Liver Diseases
    Product
    azathioprine
    Collaborators
    Not applicable
    Study date(s)
    August 2002 to May 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    None
    • Subjects who undergo liver transplantation and azathioprine tablet was administered
    • As this is PMS study, there are no exclusion criteria but contraindications are as follows.
    • Subjects with hypersensitivity to the ingredients of azathioprine tablet
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who undergo liver transplantation and azathioprine tablet was administered
    Exclusion criteria:
    • As this is PMS study, there are no exclusion criteria but contraindications are as follows.
    • Subjects with hypersensitivity to the ingredients of azathioprine tablet
    • Subjects who is pregnant or might be pregnant
    • Subjects whose white count is lower than 3000/cubic millimeter

    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
    2011-31-05

    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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