Phase 3
N=39
The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients
Thrombosis, Venous
Bottom Line
View on ClinicalTrials.gov: NCT00911157 ↗Enrolled (actual)
39
Serious AEs
5.1%
Results posted
Jun 2010
Primary outcome: Primary: Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) — 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fondaparinux sodium (Drug); unfractionated heparin (UFH) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) |
0; 0 | — |
| SECONDARY Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline |
18.5; 11.1; 81.5; 88.9; 0; 0 | — |
| SECONDARY Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10 |
0.944; 0.959; 0.015; 0.004 | — |
| SECONDARY Percentage of Participants With a Bleeding Event |
3.4; 0; 3.4; 0; 6.9; 0 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00911157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.