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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Thrombosis, Venous

Treatments

Drug: Fondaparinux sodium

Drug: unfractionated heparin (UFH)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00911157

111436

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

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