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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
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Warfarin Drug: Innohep® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2010
Primary Completion Date : April 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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®.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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
Sponsors and Collaborators
LEO Pharma
Principal Investigator: Agnes Y. Y. Lee, MD, MSc, FRCPC Director of Thrombosis, Division of Hematology, University of British Columbia, Canada

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01130025     History of Changes
Other Study ID Numbers: IN 0901 INT
2009-018141-20 ( EudraCT Number )
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vitamin K
Vitamin A
Retinol palmitate
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Fibrinolytic Agents