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Completed

NCT Number: NCT01130025

Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Diamond Health Care Centre

Vancouver, British Columbia, BC V5Z 1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warfarin

Drug

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®.

Innohep®

Drug

Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 25, 2010
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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