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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website