Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
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|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|
|Actual Primary Completion Date :||April 2014|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|