NCT01130025已完成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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Composite end-point represented by the time in days from randomisation to the first occurrence of VTE
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients with a diagnosis of active cancer.
- •Symptomatic and objectively confirmed VTE.
- •≥ 18 years of age or above the legal age of consent as per country specific regulations.
- •Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or
- •Signed informed consent.
排除标准
- •Life expectancy < 6 months.
- •Patients with basal cell carcinoma or non-melanoma skin cancer.
- •Creatinine clearance ≤ 20 ml/min.
- •Contra-indications to anticoagulation.
- •Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
- •History of heparin-induced thrombocytopenia (HIT).
- •Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours prior to randomisation.
- •Patients unlikely to comply with the protocol.
- •Participation in another interventional study.
- •Pregnant or breast-feeding women.
- •Women of childbearing potential.
研究组 & 干预措施
Innohep®
Experimental
Long-term treatment with Innohep® only.
干预措施: Innohep® (Drug)
Warfarin
Active Comparator
Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®.
干预措施: Warfarin (Drug)
结局指标
主要结局
Composite end-point represented by the time in days from randomisation to the first occurrence of VTE
时间窗: 6 months
* Symptomatic non-fatal DVTs. * Symptomatic non-fatal PEs. * Fatal PE. * Incidental proximal DVT (popliteal vein or higher). * Incidental proximal PE (segmental arteries or larger).
次要结局
- Time in days from randomisation to the first occurrence of VTE.(6 months)
研究者
研究点 (1)
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