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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01130025
First received: May 24, 2010
Last updated: June 13, 2014
Last verified: June 2014

May 24, 2010
June 13, 2014
August 2010
April 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01130025 on ClinicalTrials.gov Archive Site
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

Same as current
Not Provided
Not Provided
 
Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Thromboembolism
  • 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®.
  • Drug: Innohep®
    Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.
  • Experimental: Innohep®
    Long-term treatment with Innohep® only.
    Intervention: Drug: Innohep®
  • Active Comparator: Warfarin
    Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®.
    Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
May 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01130025
IN 0901 INT, 2009-018141-20
Yes
LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Agnes Y. Y. Lee, MD, MSc, FRCPC Director of Thrombosis, Division of Hematology, University of British Columbia, Canada
LEO Pharma
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP