EUCTR2009-018141-20-GR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: 2010年11月19日最近更新:
适应症
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 (evidence of early stage, regionally advanced or metastatic disease) or haematological
- •malignancy. Active cancer is defined as:
- •Patients diagnosed with cancer within the past 6 months, OR
- •Patients with recurrent, regionally 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 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 diagnosed within 72 hours prior to randomisation (the 72 hour count starts
- •when the diagnosis is confirmed by imaging). Diagnosis of DVT/PE must be made by
- •appropriate objective imaging
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Life expectancy < 6 months.
- •2. Patients with basal cell carcinoma or non-melanoma skin cancer where this is their only cancer diagnosis.
- •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. Increased risk of bleeding due to tumour characteristics or other condition
- •prohibiting the use of therapeutic anticoagulation according to the Investigator’s
- •d. Uncontrolled arterial hypertension (systolic blood pressure > 180 mm Hg or
- •diastolic blood pressure > 110 mm Hg).
- •e. 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.
- •f. Recent (in the last 1 month prior to randomisation) brain, spinal or ophthalmic
- •g. Thrombocytopenia (platelet count < 50 x 109/ L).
- •h. 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 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
- •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.
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