Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
- Registration Number
- NCT01130025
- Lead Sponsor
- LEO Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Innohep® Innohep® Long-term treatment with Innohep® only. Warfarin Warfarin Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada