EUCTR2008-005236-32-ES进行中（未招募）1 期
Estudio multicéntrico, abierto, de un solo grupo, de larga duración (52 semanas) sobre la inyección de dalteparina sódica (FRAGMIN®) para conocer la seguridad y eficacia en pacientes con cáncer y tromboembolia venosa sintomática
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Eisai Inc
- 入组人数
- 338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age range: subjects must be ? 18 years of age.
- •2.Male and female subjects will be eligible for enrollment.
- •3.Females should be either of non-childbearing potential as a result of surgery, radiational therapy, menopause (one year post onset), or of childbearing potential and willing to adhere to an acceptable method of contraception
- •4.Subjects must be newly diagnosed, symptomatic proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both.
- •5.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.
- •6. Prior to enrollment, subjects must not have received therapeutic doses of anticoagulant therapy (including LMWH) for > 48 hours (or > 4 doses within 48 hours). Subjects must not have received unfractionated heparin within 4 hours prior to enrollment.
- •7.ECOG performance status of 0, 1 or 2.
- •8.Subjects must have a life expectancy of > 6 months.
- •9.Subjects must have a platelet count of > 75,000 mm3.
- •10.The subject must not be on any oral anticoagulant therapy for concomitant diseases.
- •11.Subjects must have no active or serious bleeding episodes within two weeks prior to study entry.
- •12.Subjects must be able to comply with scheduled follow-ups.
- •13.Subjects must give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects who have a high risk of serious bleeding (e.g. recent neurosurgery, history of intracranial hemorrhage, acute gastroduodenal ulcer, etc.).
- •2.Subjects who are on hemodialysis.
- •3.Subjects who have a prior placement of a greenfield filter or other device to prevent embolization of DVTs.
- •4.Subjects with a known contraindication to the use of heparin (e.g. heparin-induced thrombocytopenia).
- •5.Subjects with a known hypersensitivity to heparin, dalteparin, other LMWHs or pork products.
- •6.Subjects who are currently participating in another clinical trial involving anticoagulation therapy (with the exception of aspirin), participating in a clinical trial involving anticoagulation therapy (with the exception of aspirin) in the 30 days prior to study entry, or who is actively using any investigational drugs/treatments 30 days prior to study entry involving anticoagulation therapy (with the exception of aspirin x 3).
- •7.Subject is pregnant or breast feeding.
- •8.Subjects with uncontrolled hypertension characterized by a sustained systolic pressure > 170 mmHg and/or diastolic pressure > 100 mmHg.
- •9.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.
- •10.Any condition that makes the subject unsuitable in the opinion of the investigator.
- •11.Subjects with acute leukemia.
- •12.Subjects with a genetic predisposition to clotting.
研究者
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