NCT01130025

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2010-05-25
• Last updated: 2025-02-24

Locations

1 site across 1 country: Canada