None listed
Conditions
Interventions
Group 1 Type of group
Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.
Group name:Group 2 Type of group
Warfarin 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®.
Sponsors
LEO Pharma A/S,
Eligibility
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: • Patients diagnosed with active cancer with solid tumor or hematologic cancer diagnosed histologically or cytologically • Acute proximal, symptomatic and objectively confirmed deep vein thrombosis (DVT) in lower limb (anatomically includes popliteal, femoral [superficial and common] and iliac [external and common]) and / or pulmonary embolism (PE) (located in pulmonary arteries segmental or large) diagnosed within 72 hours prior to randomization. The diagnosis of DVT / PE (in randomization and in relapse) should be made by using appropriate objective images (see Section 10.7.3.4). • Patients> 18 years of age or over the age of majority to give consent according to the specific regulations of the country. • Patients with a functional status of the Eastern Cooperative Cancer Group (ECOG) of 0, 1 or 2 before the VTE episode. • Grant signed informed consent.
Exclusion criteria
Exclusion criteria: • Life expectancy <6 months. • Patients with basal cell carcinoma or non-melanoma skin cancer. • Creatinine clearance <20 ml / min according to the abbreviated formula for the Modification of the Diet in Kidney Disease (aMDRD) (see Appendix V). • Contraindications to anticoagulation • Proven hypersensitivity to the product under investigation (Imnohep®) or to the reference product (warfarin). • History of heparin-induced thrombocytopenia (HIT). • Therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours before randomization. • Patients who had been receiving therapeutic anticoagulation at the time of the VTE event (ie ineffectiveness of the anticoagulant) • Patients whose compliance with the protocol is unlikely, eg. inability to return to study visits or inability to receive / administer daily subcutaneous injection (SC). • Participation in another interventional study that has treatment with active ingredient or a device under investigation. • Pregnant or breastfeeding women. Pregnancy should be checked by a serum or urine pregnancy test before inclusion. • Women with the ability to procreate and not protect themselves by an effective contraceptive method (according to the definition of contraception mentioned in the Informed Consent Form [ICF]) throughout the course of the study. • Sexually active fertile men if they or their partner (woman with the ability to procreate) are not using effective contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Symptomatic non-fatal DVTs. Symptomatic non-fatal PEs. Fatal PE. Incidental proximal DVT (popliteal vein or higher). Incidental proximal PE (segmental arteries or larger). Measure:Composite end-point represented by the time in days from randomisation to the first occurrence of VTE Timepoints:6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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 Measure:Time in days from randomisation to the first occurrence of VTE Timepoints:6 months | — |
Countries
Argentina, Austria, Brazil, Chile, Czech Republic, Denmark, Germany, Greece, Hong Kong, India, Israel, Italy, Korea South, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey
Contacts
Public ContactTeresa Nancy Victoria Laos
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed