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

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 specificregulations.

• Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1or 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 referenceproduct (warfarin).

• History of heparin-induced thrombocytopenia (HIT).

• Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered formore 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.