Last updated: 11/03/2018 19:19:02

Anti-Xa activity of fondaparinux for venous thromboembolism (VTE) treatmentAXaFPX

GSK study ID
116589
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: Anti-Xa activity of fondaparinux for venous thromboembolism (VTE) treatment
Trial description: Study Outline:
Collect blood sample from patients who received fondaparinux for VTE treatment and measure following items in Ex Vivo.
Inclusion criteria:
Patients who received 7.5mg or 5mg fondaparinux
Measurement: Anti-Xa activity, D-dimer, Hb
Number of subject: 15
Blood sampling:
2-3hrs after fondaparinux administration
Pre, Day1, Day4, and the next day after final administration
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
N\A
Primary outcomes:

Change of anti-Xa activity

Timeframe: At day 0, 1, 4, 7

Secondary outcomes:

Change of D-dimer

Timeframe: At day 0, 1, 4, 7

Change of Hemoglobin (Hb)

Timeframe: At day 0, 1, 4, 7

Interventions:
  • Drug: Arixtra
    • Enrollment:
    15
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Thrombosis, Venous and Embolism, Pulmonary
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    January 2012 to May 2013
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 75 Year
    Accepts healthy volunteers
    none
    • VTE patients who treated by Fondaparinux
    Inclusion and exclusion criteria
    Inclusion criteria:
    • VTE patients who treated by Fondaparinux

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-10-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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