Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Composite end-point represented by the time in days from randomisation to the first occurrence of VTE [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Symptomatic non-fatal DVTs.
- Symptomatic non-fatal PEs.
- Fatal PE.
- Incidental proximal DVT (popliteal vein or higher).
- Incidental proximal PE (segmental arteries or larger).
- Time in days from randomisation to the first occurrence of VTE. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- 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
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Long-term treatment with Innohep® only.
Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.
Active Comparator: Warfarin
Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®.
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®.
|Contact: Lars Rosendal, MSc, PhD||+45 email@example.com|
|Contact: Charlotte Irps||+44 firstname.lastname@example.org|
|Canada, British Columbia|
|Diamond Health Care Centre||Recruiting|
|Vancouver, British Columbia, Canada, BC V5Z 1M9|
|Contact: Agnes Y.Y. Lee, MD, MSc, FRCPC +1 604-875-4952 email@example.com|
|Principal Investigator:||Agnes Y. Y. Lee, MD, MSc, FRCPC||Director of Thrombosis, Division of Hematology, University of British Columbia, Canada|