Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer

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

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.

Inclusion Criteria:

• 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 2.
• Signed informed consent.

Exclusion Criteria:

• 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.