NCT00311090

Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs

International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 757 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The three purposes of this study are the following: * To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk; * To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment; * To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

Detailed description

The study consists in a 6-month treatment period followed by an observational period of 3 to 6 months with a month 9 visit and a phone/contact visit at month 12. All participants who complete the 6-month treatment period are re-randomized to either the idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect sub-study.

Conditions

• Deep Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Idrabiotaparinux sodium	0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection
DRUG	Idraparinux sodium	0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection
DRUG	Avidin	100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes
DRUG	Placebo (for Avidin)	Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-04-05
• Last updated: 2016-03-21

Locations

20 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Russia, South Africa, Spain, Turkey (Türkiye)