NCT00942968已完成4 期
FRAG-A001-401: Dalteparin Sodium Injection (Fragmin), Multicenter, Open-Label, Single-arm, Long Term (52 Weeks) Study for Understanding the Safety and Efficacy in Subjects With Malignancies and Symptomatic Venous Thromboembolism
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 338
- 试验地点
- 42
- 主要终点
- Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
研究概览
简要总结
The purpose of this study is to determine the long term tolerability and safety of dalteparin in subjects with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, age greater than or equal to 18 years of age.
- •Females should be either of non-childbearing potential as a result of surgery, radiation therapy, menopause (one year post onset), or of childbearing potential and willing to adhere to an acceptable method of pregnancy prevention.
- •Subjects must be newly diagnosed, symptomatic proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both.
- •Subjects must have active malignancy defined as a diagnosis of cancer (excluding basal cell or squamous cell carcinoma of the skin) within six months before enrollment, having received any treatment for cancer within the previous six months, or having documented recurrent or metastatic cancer.
- •Prior to enrollment, subjects must not have received therapeutic doses of anticoagulant therapy (including low molecular weight heparin [LMWH]) for >48 hours (or >4 doses within 48 hours).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- •Subjects must have a life expectancy of >6 months.
- •Subjects must have a platelet count of >75,000 mm^
- •The subject must not be on any oral anticoagulant therapy for concomitant diseases.
- •Subjects must have no active or serious bleeding episodes within two weeks prior to study entry.
- •Subjects must be able to comply with scheduled follow-ups.
排除标准
- •Subjects who have a high risk of serious bleeding (e.g., recent neurosurgery within 30 days, history of intracranial hemorrhage, acute gastroduodenal ulcer, etc.).
- •Subjects who are on hemodialysis.
- •Subjects who have a prior placement of a Greenfield filter or other device to prevent embolization of deep vein thromboses.
- •Subjects with a known contraindication to the use of heparin (e.g., heparin-induced thrombocytopenia).
- •Subjects with a known hypersensitivity to heparin, dalteparin sodium, other LMWHs or pork products.
- •Subjects who are currently participating in another clinical trial involving anticoagulation therapy (with the exception of acetylsalicylic acid (ASA) in the 30 days prior to study entry, or who are actively using any investigational drugs/treatments 30 days prior to study entry involving anticoagulation therapy (with the exception of ASA , t.i.d).
- •Subject is pregnant or breast feeding.
- •Subjects with uncontrolled hypertension characterized by a sustained systolic pressure >170 mmHg and/or diastolic pressure >100 mmHg.
- •Subjects with a serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the subject's ability to complete the study.
- •Any condition that makes the subject unsuitable in the opinion of the investigator.
- •Subjects with leukemia or myeloproliferative syndrome.
研究组 & 干预措施
1
Experimental
干预措施: dalteparin (Drug)
结局指标
主要结局
Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
时间窗: Month 7 up to Month 12
A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of \>=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.
Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
时间窗: Month 7 up to Month 12
VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (adjudicated by Central Adjudication Committee) were reported.
次要结局
- Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee(Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12)
- Number of Participants With Investigator Identified Major Bleeding Events(Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12)
- Number of Participants With Fatal Bleeding Events(Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12)
- Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee(Month 1 up to Month 12)
- Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)(Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12)
- Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)(Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12)
- Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee(Month 1 up to Month 12)
- Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee(Month 1 up to Month 12)
- Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee(Month 1 up to Month 12)
- Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee(Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12)
研究者
研究点 (42)
Loading locations...
相似试验
已完成
不适用
Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical PracticeAcute Coronary SyndromeNCT00922766Pfizer618
已完成
不适用
Effectiveness of dalteparin therapy as intervention in recurrent pregnancy lossPregnant women with a history of recurrent pregnancy lossPregnancy and ChildbirthPregnancy lossISRCTN53717039Friedrich Schiller University Jena (Friedrich-Schiller-Universität Jena) (Germany)449
进行中（未招募）
不适用
Effectiveness of Dalteparin Therapy as Intervention in recurrent pregnancy loss - EHTIG IIPregnant women with a history of recurrent pregnancy loss, defined as:-2 or more early (< 12 weeks of gestation) pregnancy losses or-1 or more late (> 12 weeks of gestation) pregnancy lossMedDRA version: 8.1Level: LLTClassification code 10036562Term: Pregnancy in habitual aborterEUCTR2006-001984-53-DEFriedrich-Schiller-Universität Jena486
进行中（未招募）
不适用
Effectiveness of Dalteparin Therapy as Intervention in recurrent pregnancy loss - EHTIG IIPregnant women with a history of recurrent pregnancy loss, defined as:-2 or more early (< 12 weeks of gestation) pregnancy losses or-1 or more late (> 12 weeks of gestation) pregnancy lossMedDRA version: 8.1Level: LLTClassification code 10036562Term: Pregnancy in habitual aborterEUCTR2006-001984-53-ATFriedrich-Schiller-Universität Jena486
已完成
3 期
Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a CatheterChronic Myeloproliferative DisordersLymphomaLeukemiaCervical CancerMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous/Nonmalignant ConditionUnspecified Adult Solid Tumor, Protocol SpecificVeno-occlusive DiseaseNCT00006083Jonsson Comprehensive Cancer Center