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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Biotin; Idrabiotaparinux; Idraparinux; SANORG 34006

Criteria

Inclusion Criteria:

• Confirmed acute symptomatic DVT of the lower limbs

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.