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

Phase 3

Completed

Interventions: Drug: Idrabiotaparinux sodium
Drug: Idraparinux sodium
Drug: Avidin
Drug: Placebo (for Avidin)

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension)
Active bleeding or high risk for bleeding.
Pregnancy or childbearing potential without proper contraceptive measures.
Breastfeeding
Known allergy to idraparinux, SSR126517E, or egg proteins
Indication of prolonged anticoagulation for other reason than DVT of the lower limbs
Symptomatic pulmonary embolism (PE)
Life expectancy < 6 months.

Arm && Interventions

Group	Intervention	Description
Idrabiotaparinux	Placebo (for Avidin)	Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months. In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration)
Idraparinux	Placebo (for Avidin)	Idraparinux sodium, 2.5 mg, once-weekly for 6 months In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration)
Idrabiotaparinux	Idrabiotaparinux sodium	Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months. In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration)
Idraparinux	Idraparinux sodium	Idraparinux sodium, 2.5 mg, once-weekly for 6 months In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration)
Idrabiotaparinux	Avidin	Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months. In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration)

Primary Outcome Measures

Name	Time	Method
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters	Day 183
Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion	Day 183 to Day 188

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations	Days 15, 36, 57, 92 and 183
Safety: number of participants with clinically relevant bleedings and number of deaths as confirmed by a Central Independent Adjudication Committee (CIAC)	First 6 months
Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC	First 6 months

Locations (7): Sanofi-aventis
🇷🇺
Moscow, Russian Federation
sanofi-aventis Mexico
🇲🇽
Mexico, Mexico
sanofi-aventis Turkey
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Istanbul, Turkey
sanofi-aventis France
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Paris, France
sanofi-aventis Israel
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Natanya, Israel
sanofi-aventis, Netherlands
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Gouda, Netherlands
Sanofi-Aventis
🇪🇸
Barcelona, Spain