The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
The dose of Fondaparinux will be determined based on a subject's body weight (\< 50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection.
UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Fukuoka, Japan
Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
VTE (pulmonary thromboembolism \[PE\] and/or deep vein thrombosis \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).
Time frame: From Day 1 to Day 90 (±7 days)
Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)
VTE (pulmonary thromboembolism \[PE\] and/or deep vein thrombosis \[DVT\]) was adjudicated blindly by the CIACE.
Time frame: From Day 1 to Day 90 (±7 days)
Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline
Classifications of "Improved," "No change," or "Worse" were adjudicated blindly by the CIACE.
Time frame: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10
Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).
Time frame: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
Percentage of Participants With a Bleeding Event
Bleeding events (major bleeding \[clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin \>=2 grams (g)/deciliter (dL), or a transfusion \>=2 units\]; minor bleeding \[clinically overt bleeding and not adjudicated as major bleeding\], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).
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GSK Investigational Site
Gunma, Japan
GSK Investigational Site
Gunma, Japan
GSK Investigational Site
Hiroshima, Japan
GSK Investigational Site
Hiroshima, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hyōgo, Japan
...and 14 more locations
Time frame: Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).