Last updated: 11/03/2018 12:55:27

Drug Use Investigation for IMURAN tablet (heart transplant)

GSK study ID
112344
See study documents
Clinicaltrials.gov ID
Not applicable
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 tablet (heart transplant)
Trial description: This post-marketing surveillance (PMS) is conducted to evaluate the efficacy and safety of azathioprine tablets after heart transplant under conditions of actual use.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Onset status of rejection

Timeframe: 1 year

Subject’s survival or death

Timeframe: 1 year

Incidence of adverse events related to azathioprine tablets

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Azathioprine tablet
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    antirejection
    Product
    azathioprine
    Collaborators
    Not applicable
    Study date(s)
    May 2011 to May 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Patients who underwent heart transplant
    • Azathioprine tablet was administered
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients who underwent heart transplant
    • Azathioprine tablet was administered
    Exclusion criteria:
    • Not applicable

    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
    Not applicable

    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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    Access to clinical trial data by researchers
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