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

LEO Pharma900 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

900

Conditions

Venous Thromboembolism

Interventions

WarfarinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Diamond Health Care Centre

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Composite end-point represented by the time in days from randomisation to the first occurrence of VTE

* Symptomatic non-fatal DVTs. * Symptomatic non-fatal PEs. * Fatal PE. * Incidental proximal DVT (popliteal vein or higher). * Incidental proximal PE (segmental arteries or larger).

Time frame: 6 months

Secondary Outcomes

Time in days from randomisation to the first occurrence of VTE.

* 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

Time frame: 6 months

Data from ClinicalTrials.gov

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