The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Phase 3

Completed

• Conditions: Thrombosis, Venous
• Interventions: Drug: unfractionated heparin (UFH); Drug: Fondaparinux sodium

• Registration Number: NCT00911157
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2010-05-13
• Results First Submitted QC: 2010-05-13
• Results First Posted: 2010-06-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Confirmed diagnosis of acute proximal DVT based on contrast-enhanced Multi detector-row CT (MDCT) (not more than 10 days after the onset of the symptoms of DVT)
• Age:20 years
• Gender: No restriction
• Hospitalization status: Subjects who are able to stay at the hospital at least during the initial treatment period
• Written informed consent from the subject him/herself or his/her legally acceptable representative. Written informed consent from the subject's legally acceptable representative must be obtained if the subject is incapable of giving consent

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Exclusion Criteria

• Symptomatic PE
• Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current DVT
• Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present
• Anticoagulant therapy for at least 24 hours to treat the current episode prior to entry into the study
• Active, clinically significant bleeding
• Thrombocytopenia (platelet count <10×10⁴/µL at screening)
• Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension, or severe diabetes) or bleeding tendency
• Severe hepatic disorder
• Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
• Previous history of cerebral hemorrhage
• Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
• Previous history of Heparin-induced thrombocytopenia
• Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant)
• Severe renal disorder (serum creatinine >2.0 mg/dL [180 µmol/L] at screening) in a well hydrated subject
• QT interval prolonged (QT interval corrected by Bazett's formula [QTcB] ≥450 msec; for patients with bundle branch block QTcB ≥480 msec) at screening
• Documented hypersensitivity to contrast media
• Use of any contraindicated drug that cannot be combined with the injection of contrast medium [e.g., antihyperglycemics, such as biguanides (metformin hydrochloride, buformin hydrochloride)]
• Participation in any other therapeutic drug study or a clinical study within 6 months prior to entry into this study
• Previous participation in a study of GSK576428 [Fondaparinux Sodium; including the studies of Org31540/SR90107A (ex-project code)] or previous exposure to the therapeutic dose of GSK576428
• Drug or alcohol abuse
• Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
• Recent surgery within 3 days prior to entry into the study
• Life expectancy <3 months
• Pregnant women, nursing mothers, women who may be pregnant, or women contemplating pregnancy during the study period
• Others whom the investigator or subinvestigator considers not eligible for the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unfractionated heparin	unfractionated heparin (UFH)	-
Fondaparinux	Fondaparinux sodium	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)	From Day 1 to Day 90 (±7 days)	VTE (pulmonary thromboembolism \[PE\] and/or deep vein thrombosis \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)	From Day 1 to Day 90 (±7 days)	VTE (pulmonary thromboembolism \[PE\] and/or deep vein thrombosis \[DVT\]) was adjudicated blindly by the CIACE.
Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline	Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)	Classifications of "Improved," "No change," or "Worse" were adjudicated blindly by the CIACE.
Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10	Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)	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).
Percentage of Participants With a Bleeding Event	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).	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).

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan