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

• ClinicalTrials.gov Identifier: NCT01130025
• Recruitment Status: Completed
• First Posted: May 25, 2010
• Last Update Posted: June 16, 2014
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

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 Design

• 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
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

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®.

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kahale LA, Matar CF, Hakoum MB, Tsolakian IG, Yosuico VE, Terrenato I, Sperati F, Barba M, Schunemann H, Akl EA. Anticoagulation for the initial treatment of venous thromboembolism in people with cancer. Cochrane Database Syst Rev. 2021 Dec 8;12(12):CD006649. doi: 10.1002/14651858.CD006649.pub8.

Bauersachs R, Lee AYY, Kamphuisen PW, Meyer G, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study. Thromb Haemost. 2018 May;118(5):914-921. doi: 10.1055/s-0038-1641150. Epub 2018 Apr 4.

Lee AYY, Kamphuisen PW, Meyer G, Bauersachs R, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer: A Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):677-686. doi: 10.1001/jama.2015.9243. Erratum In: JAMA. 2017 Nov 28;318(20):2048.

Lee AY, Bauersachs R, Janas MS, Jarner MF, Kamphuisen PW, Meyer G, Khorana AA; CATCH Investigators. CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients. BMC Cancer. 2013 Jun 13;13:284. doi: 10.1186/1471-2407-13-284.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01130025
• Other Study ID Numbers: IN 0901 INT; 2009-018141-20 ( EudraCT Number )
• First Posted: May 25, 2010
• Last Update Posted: June 16, 2014
• Last Verified: June 2014

Additional relevant MeSH terms:

Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Tinzaparin; Warfarin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action