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
18 Years
N/A
Both
Venous Thromboembolism
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Composite end-point represented by the time in days from randomisation to the first occurrence of VTE
Outcome Description:
Symptomatic non-fatal DVTs. Symptomatic non-fatal PEs. Fatal PE. Incidental proximal DVT (popliteal vein or higher). Incidental proximal PE (segmental arteries or larger).
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Agnes Y. Y. Lee, MD, MSc, FRCPC
Investigator Role:
Principal Investigator
Investigator Affiliation:
Director of Thrombosis, Division of Hematology, University of British Columbia, Canada
Authority:
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study ID:
IN 0901 INT
NCT ID:
NCT01130025
Start Date:
August 2010
Completion Date:
April 2014
Related Keywords:
- Venous Thromboembolism
- Thromboembolism
- Venous Thromboembolism
- Venous Thrombosis
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