Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
This study is currently recruiting participants.
Verified December 2012 by LEO Pharma
Sponsor:
LEO Pharma
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01130025
First received: May 24, 2010
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism |
Drug: Warfarin Drug: Innohep® |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by LEO Pharma:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 900 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Innohep®
Long-term treatment with Innohep® only.
|
Drug: Innohep®
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®.
|
Drug: Warfarin
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®.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130025
Contacts
| Contact: Lars Rosendal, MSc, PhD | +45 41883006 | lars.rosendal@leo-pharma.com |
| Contact: Charlotte Irps | +44 1844276310 | charlotte.irps@leo-pharma.com |
Locations
| 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 alee14@bccancer.bc.ca | |
Sponsors and Collaborators
LEO Pharma
Investigators
| Principal Investigator: | Agnes Y. Y. Lee, MD, MSc, FRCPC | Director of Thrombosis, Division of Hematology, University of British Columbia, Canada |
More Information
No publications provided
| Responsible Party: | LEO Pharma |
| ClinicalTrials.gov Identifier: | NCT01130025 History of Changes |
| Other Study ID Numbers: | IN 0901 INT, 2009-018141-20 |
| Study First Received: | May 24, 2010 |
| Last Updated: | December 21, 2012 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Austria: Agency for Health and Food Safety Brazil: National Health Surveillance Agency Bulgaria: Bulgarian Drug Agency Canada: Health Canada Chile: Instituto de Salud Publica de Chile Colombia: National Institutes of Health Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Egypt: Ministry of Health, Drug Policy and Planning Center Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Guatemala: Ministry of Public Health and Social Assistance India: Central Drugs Standard Control Organization Israel: Ministry of Health Italy: Ministry of Health Jordan: Jordanian Food and Drug Administration Latvia: State Agency of Medicines Lebanon: Ministry of Public Health Hong Kong: Ministry of Health Mexico: Ministry of Health Peru: Instituto Nacional de Salud Poland: The Central Register of Clinical Trials Portugal: National Pharmacy and Medicines Institute Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Saudi Arabia: Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Spain: Agencia Española de Medicamentos y Productos Sanitarios Taiwan: Department of Health Thailand: Ministry of Public Health Ukraine: Ministry of Health |
Additional relevant MeSH terms:
|
Warfarin Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Vitamin K Vitamins Tinzaparin Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Hematologic Agents Therapeutic Uses Anticoagulants Fibrinolytic Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013