Last updated: 11/03/2018 17:22:15
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)

GSK study ID
114877
See study documents
Clinicaltrials.gov ID
NCT01416311
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)
Trial description: To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects receiving the drug until data from a specified number of subjects are accumulated to identify factors considered to influence its safety and efficacy.
<Priority investigation item>
Thromboembolism
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of subjects with any adverse events treated with REVOLADE

Timeframe: 1 year

Secondary outcomes:

Appearance of thromboembolism

Timeframe: 1 year

Interventions:
  • Drug: Eltrombopag
    • Enrollment:
    1000
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Purpura, Thrombocytopaenic, Idiopathic
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    December 2010 to October 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Subjects with chronic idiopathic thrombocytopenic purpura
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with chronic idiopathic thrombocytopenic purpura
    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
    No longer a GSK study
    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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