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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Retinol palmitate; Tinzaparin; Vitamin A; Vitamin K; Warfarin

Criteria

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.