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
- Conditions
- -I26I26
- Registration Number
- PER-066-10
- Lead Sponsor
- EO Pharma A/S,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 36
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Symptomatic non-fatal DVTs.<br>Symptomatic non-fatal PEs.<br>Fatal PE.<br>Incidental proximal DVT (popliteal vein or higher).<br>Incidental proximal PE (segmental arteries or larger).<br><br>Measure:Composite end-point represented by the time in days from randomisation to the first occurrence of VTE<br>Timepoints:6 months<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The 5 individual components of the composite primary efficacy endpoint.<br>A composite endpoint of symptomatic DVT and/or PE, including fatal PE.<br>Safety endpoints will consist of bleeding and overall mortality<br><br><br>Measure:Time in days from randomisation to the first occurrence of VTE<br>Timepoints:6 months<br>