NCT00911157已完成3 期
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fondaparinux
Experimental
干预措施: Fondaparinux sodium (Drug)
unfractionated heparin
Other
干预措施: unfractionated heparin (UFH) (Drug)
结局指标
主要结局
Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
时间窗: From Day 1 to Day 90 (±7 days)
VTE (pulmonary thromboembolism \[PE\] and/or deep vein thrombosis \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).
次要结局
- Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)(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(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(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(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).)
研究者
研究点 (1)
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