Last updated: 11/07/2018 03:23:46
The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of participants with recurrent or new symptomatic venous thromboembolism (VTE)
Timeframe: From Day 1 to Day 90 (±7 days)
Secondary outcomes:
Percentage of participants with recurrent or new symptomatic/asymptomatic VTE (by type)
Timeframe: From Day 1 to Day 90 (±7 days)
Percentage of participants with perfusion lung scan results scored as improved, no change, or worse compared to Baseline
Timeframe: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
Total perfusion score at baseline and mean change from baseline at Day 5-10
Timeframe: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
Percentage of participants with a Bleeding event
Timeframe: 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).
Interventions:
Drug: Fondaparinux sodium
Drug: unfractionated heparin (UFH)
Enrollment:
39
Observational study model:
Not applicable
Primary completion date:
2009-18-11
Time perspective:
Not applicable
Clinical publications:
Mashio Nakamura, Yoshiaki Okano, Hiroki Minamiguchi, Mitsuru Munemasa, Masahiro Sonoda, Norikazu Yamada, Kazuhiko Hanzawa, Narumi Aoyagi, Hiroshi Tsujimoto, Nobuaki Sarai, Hiromu Nakajima,Takeyoshi Kunieda. Multidetector-Row Computed Tomography-Based Clinical Assessment of Fondaparinux for Treatment of Acute Pulmonary Embolism and Acute Deep Vein Thrombosis in Japanese Patients. [Circ J]. 2011;75:1424.
Mashio Nakamura, Yoshiaki Okano, Hiroki Minamiguchi, Mitsuru Munemasa, Masahiro Sonoda, Norikazu Yamada, Kazuhiko Hanzawa, Narumi Aoyagi, Hiroshi Tsujimoto, Nobuaki Sarai, Hiromu Nakajima,Takeyoshi Kunieda.Multidetector-Row Computed Tomography-Based Clinical Assessment of Fondaparinux for Treatment of Acute Pulmonary Embolism and Acute Deep Vein Thrombosis in Japanese Patients.Circ J.2011;75(6):1424-32
Medical condition
Thrombosis, Venous
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
June 2008 to November 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- 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)
- Symptomatic PE
- Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current DVT
Inclusion and exclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-18-11
Actual study completion date
2009-18-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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