Venous Thromboembolism
Conditions
Brief 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.
Interventions
DRUGWarfarin
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®.
DRUGInnohep®
Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite end-point represented by the time in days from randomisation to the first occurrence of VTE | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in days from randomisation to the first occurrence of VTE. | 6 months | * 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 |
Countries
Canada
Outcome results
None listed