CTRI/2010/091/000598进行中（未招募）3 期
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 - DVT study
EO Pharma AS0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
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 deep vein thrombosis (DVT) (anatomically including popliteal, femoral [superficial and common] and iliac [external and common]) and/or pulmonary embolism (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.
- •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.
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.
- •4.Contra-indications to anticoagulation:
- •a.Active or recent (< 1 month) 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 randomisa-tion) brain, spinal or ophthalmic surgery.
- •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 low molecular weight heparin [LMWH] /unfractionated heparin [UFH])
- •5.Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
- •6.History of heparin-induced thrombocytopenia (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 antagonists (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
- •9.Patients unlikely to comply with the protocol, e.g. inability to return for study visits or inability to receive/administer daily subcutaneous (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 inclusion.
- •12.Women of childbearing potential not protected by an effective contraceptive method (as defined for contra-ception 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
相似试验
进行中（未招募）
不适用
Comparison of treatment of blood clots in the veins of the leg / pelvis as well as of blood clots in the lung of patients with active cancer. The treatments compared are Innohep® Treatment Versus Warfarin , an oral Vitamin K antagonist.EUCTR2009-018141-20-LVEO Pharma A/S900
进行中（未招募）
不适用
Comparison of treatment of blood clots in the veins of the leg / pelvis as well as of blood clots in the lung of patients with active cancer. The treatments compared are Innohep® Treatment Versus Warfarin , an oral Vit. K antagonist.EUCTR2009-018141-20-PTEO Pharma A/S900
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 - CATCHThromboembolism (VTE) in patients with active cancerMedDRA version: 12.1Level: LLTClassification code 10066899Term: Venous thromboembolismEUCTR2009-018141-20-GREO Pharma A/S900
进行中（未招募）
不适用
Comparison of treatment of blood clots in the veins of the leg / pelvis as well as of blood clots in the lung of patients with active cancer. The treatments compared are Innohep® Treatment Versus Warfarin , an oral Vit. K antagonist.Thromboembolism (VTE) in patients with active cancerMedDRA version: 14.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866EUCTR2009-018141-20-DEEO Pharma A/S900
进行中（未招募）
不适用
Comparison of treatment of blood clots in the veins of the leg / pelvis as well as of blood clots in the lung of patients with active cancer. The treatments compared are Innohep® Treatment Versus Warfarin , an oral Vit. K antagonist.Thromboembolism (VTE) in patients with active cancerMedDRA version: 15.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866EUCTR2009-018141-20-ATEO Pharma A/S900