Overview

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

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Calcium heparin
Fondaparinux
Heparin
PENTA
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