Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: May 24, 2010
Last updated: June 13, 2014
Last verified: June 2014
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2014 (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®.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01130025
|Diamond Health Care Centre
|Vancouver, British Columbia, Canada, BC V5Z 1M9 |
||Agnes Y. Y. Lee, MD, MSc, FRCPC
||Director of Thrombosis, Division of Hematology, University of British Columbia, Canada
No publications provided by LEO Pharma
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
History of Changes
|Other Study ID Numbers:
||IN 0901 INT, 2009-018141-20
|Study First Received:
||May 24, 2010
||June 13, 2014
||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 Pública 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:
ClinicalTrials.gov processed this record on August 03, 2015
Embolism and Thrombosis
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action