EUCTR2009-018141-20-LV进行中（未招募）不适用
Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation with a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT - CATCH
EO Pharma A/S0 个研究点目标入组 900 人开始时间: 2012年3月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
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. Patients with a diagnosis of active cancer with a histologically or cytologically diagnosed
- •solid tumour or haematological malignancy (evidence of early stage, regional or metastatic
- •disease). Active cancer is defined as:
- •Patients diagnosed with cancer within the past 6 months, OR
- •Patients with recurrent, advanced or metastatic disease, OR
- •Patients that have received any treatment for cancer during the previous 6 months, OR
- •Patients not in complete remission of a chronic haematological malignancy.
- •2. Symptomatic and objectively confirmed acute proximal lower-limb DVT (anatomically
- •including popliteal, femoral [superficial and common] and iliac [external and common])
- •and/or PE (located in segmental or larger pulmonary arteries) diagnosed within 72 hours prior to randomisation. Diagnosis of DVT/PE (at randomisation and at recurrence) must be made by appropriate objective imaging (see Section 10.7.3.4).
- •3. = 18 years of age or above the legal age of consent as per country specific regulations.
- •4. Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 prior to the VTE episode.
- •5. Signed 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 585
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 315
排除标准
- •1. Life expectancy < 6 months.
- •2. Patients with basal cell carcinoma or non-melanoma skin cancer
- •3. Creatinine clearance = 20 ml/min according to the abbreviated Modification of Diet in Renal Disease (aMDRD) formula (see Appendix V).
- •4. Contra-indications to anticoagulation:
- •a. Active or recent (< 1 months) clinically significant bleeding, including
- •gastrointestinal bleeding or peptic ulcer.
- •b. History of bleeding disorder or coagulopathy (congenital, acquired or unexplained
- •repeated bleeding episodes).
- •c. Uncontrolled arterial hypertension (systolic blood pressure > 180 mm Hg or
- •diastolic blood pressure > 110 mm Hg).
- •d. Recent intracranial haemorrhage (in the last 1 month prior to randomisation) which
- •is at high risk of rebleeding and would prohibit anticoagulant therapy, according to
- •the Investigator’s judgment.
- •e. Recent (in the last 1 month prior to randomisation) brain, spinal or ophthalmic
- •f. Thrombocytopenia (platelet count < 50 x 109/ L).
- •g. Coagulopathy due to liver insufficiency as indicated by a prolonged baseline
- •activated partial thromboplastin time (aPTT) > 1.5 x upper limit of normal (ULN) or
- •equivalent to an aPTT ratio > 1.5 (if not receiving LMWH/ unfractionated heparin
- •5. Known hypersensitivity to the investigational product (Innohep®) or reference product (warfarin).
- •6. History of HIT.
- •7. Pre-randomisation therapeutic anticoagulant treatment for the current acute VTE administered for more than 72 hours prior to randomisation.
- •8. Patients that had been receiving therapeutic anticoagulation at the time of the VTE event (i.e. anticoagulant failure), using any anticoagulant, such as:
- •a. Parenteral anticoagulants e.g. UFH, LMWH, fondaparinux, bivalirudin or hirudin.
- •b. Vitamin K antagonist (VKA).
- •c. New oral anticoagulants, e.g. dabigatran, rivaroxaban.
- •Note: Chronic treatment with anti-platelet agents such as low dose of aspirin (up to
- •325 mg/day), clopidogrel or ticlopidine is allowed.
- •9. Patients unlikely to comply with the protocol, e.g. inability to return for study visits or inability to receive/administer daily SC injection.
- •10. Participation in another interventional study with active drug treatment or an investigational device.
- •11. Pregnant or breast-feeding women. Pregnancy status should be checked by serum or urine pregnancy testing prior to randomisation.
- •12. Women of childbearing potential not protected by an effective contraceptive method of birth control (as defined for contraception in the Informed Consent Form [ICF]) for the duration of the study.
- •13. Sexually active fertile men if they, or their partner (being a woman of childbearing
- •potential), is not using effective birth control.
研究者
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