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

February 21, 2025 updated by: LEO Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, BC V5Z 1M9
        • Diamond Health Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Agnes Y. Y. Lee, MD, MSc, FRCPC, Director of Thrombosis, Division of Hematology, University of British Columbia, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimated)

May 25, 2010

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN 0901 INT
  • 2009-018141-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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