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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01130025
First received: May 24, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Venous Thromboembolism
Drug: Warfarin
Drug: Innohep®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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



Enrollment: 900
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130025

Locations
Canada, British Columbia
Diamond Health Care Centre
Vancouver, British Columbia, Canada, BC V5Z 1M9
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Agnes Y. Y. Lee, MD, MSc, FRCPC Director of Thrombosis, Division of Hematology, University of British Columbia, Canada
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01130025     History of Changes
Other Study ID Numbers: IN 0901 INT, 2009-018141-20
Study First Received: May 24, 2010
Last Updated: November 13, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Agency for Health and Food Safety
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Colombia: National Institutes of Health
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health, Drug Policy and Planning Center
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Guatemala: Ministry of Public Health and Social Assistance
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Italy: Ministry of Health
Jordan: Jordanian Food and Drug Administration
Latvia: State Agency of Medicines
Lebanon: Ministry of Public Health
Hong Kong: Ministry of Health
Mexico: Ministry of Health
Peru: Instituto Nacional de Salud
Poland: The Central Register of Clinical Trials
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Saudi Arabia: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Department of Health
Thailand: Ministry of Public Health
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Vitamin K
Vitamins
Tinzaparin
Warfarin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Anticoagulants
Fibrinolytic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014