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

LEO Pharma

Status and phase

Completed

Phase 3

Conditions

Venous Thromboembolism

Treatments

Drug: Innohep®

Drug: Warfarin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01130025

2009-018141-20 (EudraCT Number)

IN 0901 INT

Details and patient eligibility

About

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.

Enrollment

900 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.