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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Deep Venous Thrombosis

Treatments: Drug: Placebo (for Avidin); Drug: Idraparinux sodium; Drug: Idrabiotaparinux sodium; Drug: Avidin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311090

2005-005326-30 (EudraCT Number)

EFC5945

Details and patient eligibility

About

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.

Full 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.

Enrollment: 757 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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757 participants in 2 patient groups

Idrabiotaparinux

Experimental group

Description:

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)

Treatment:

Drug: Avidin

Drug: Placebo (for Avidin)

Drug: Idrabiotaparinux sodium

Idraparinux

Active Comparator group

Description:

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)

Treatment:

Drug: Placebo (for Avidin)

Drug: Idraparinux sodium