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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Warfarin
* Drug: Innohep®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Innohep®<br>Long-term treatment with Innohep® only. | Drug: Innohep®<br>* Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.<br>|
| Active Comparator: Warfarin<br>Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®. | Drug: Warfarin<br>* Tablets. Once daily for 6 months (180 days) to maintain therapeutic international normalised ratio (INR) levels in combination with initial (5-10 days) overlapping treatment with Innohep®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite end-point represented by the time in days from randomisation to the first occurrence of VTE | Symptomatic non-fatal DVTs. Symptomatic non-fatal PEs. Fatal PE. Incidental proximal DVT (popliteal vein or higher). Incidental proximal PE (segmental arteries or larger). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in days from randomisation to the first occurrence of VTE. | The 5 individual components of the composite primary efficacy endpoint. A composite endpoint of symptomatic DVT and/or PE, including fatal PE. Safety endpoints will consist of bleeding and overall mortality | 6 months |