The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients
Condition: Thrombosis, Venous
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Fondaparinux sodium; unfractionated heparin (UFH)
Intervention description: 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.
Intervention MeSH terms: Heparin; Calcium heparin; PENTA; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Pulmonary thromboembolism; contrast-enhanced MDCT; Deep Vein Thrombosis; Fondaparinux sodium

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.
    

Eligibility criteria:

        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