Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
|ClinicalTrials.gov Identifier: NCT01130025|
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : June 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: Warfarin Drug: Innohep®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2010|
|Primary Completion Date :||April 2014|
|Study Completion Date :||May 2014|
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®.
- Composite end-point represented by the time in days from randomisation to the first occurrence of VTE [ Time Frame: 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).
- Time in days from randomisation to the first occurrence of VTE. [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130025
|Canada, British Columbia|
|Diamond Health Care Centre|
|Vancouver, British Columbia, Canada, BC V5Z 1M9|
|Principal Investigator:||Agnes Y. Y. Lee, MD, MSc, FRCPC||Director of Thrombosis, Division of Hematology, University of British Columbia, Canada|